<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04432584</url>
  </required_header>
  <id_info>
    <org_study_id>BO42161</org_study_id>
    <secondary_id>2020-000597-26</secondary_id>
    <nct_id>NCT04432584</nct_id>
  </id_info>
  <brief_title>A Study Evaluating The Safety, Pharmacokinetics, and Efficacy Of Crovalimab Versus Eculizumab In Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors</brief_title>
  <acronym>COMMODORE 1</acronym>
  <official_title>A Phase III, Randomized, Open-Label, Active-Controlled, Multicenter Study Evaluating The Safety, Pharmacokinetics, Pharmacodynamic And Efficacy of Crovalimab Versus Eculizumab In Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Chugai Pharmaceutical</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A study designed to evaluate the safety of crovalimab with eculizumab in participants with&#xD;
      PNH currently treated with complement inhibitors. This study will enroll approximately 190&#xD;
      participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 30, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2029</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2029</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants with Adverse Events (AEs) and by Severity</measure>
    <time_frame>Up to approximately 8 years</time_frame>
    <description>Determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5 (CTCAE v5).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants with Injection- Site Reactions, Infusion-Related Reactions, Hypersensitivity and Infections (including Meningococcal Meningitis)</measure>
    <time_frame>Up to approximately 8 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants with Adverse Events (AEs) Leading to Study Drug Discontinuation</measure>
    <time_frame>Up to approximately 8 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants with Clinical Manifestations of Drug-Target-Drug Complex (DTDC) Formation Amongst Those Participants who Switched to Crovalimab Treatment from Eculizumab Treatment or Ravulizumab Treatment</measure>
    <time_frame>Up to approximately 8 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum Concentrations of Crovalimab or Eculizumab Over Time</measure>
    <time_frame>Up to approximately 8 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Concentrations of Ravulizumab at the time of Crovalimab Initiation</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Anti-Crovalimab Antibodies</measure>
    <time_frame>Up to approximately 8 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pharmacodynamic (PD) Biomarker Complement Activity (CH50) Over Time</measure>
    <time_frame>Up to approximately 8 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change Over Time in Free C5 Concentration in Crovalimab-Treated Participants</measure>
    <time_frame>Up to approximately 8 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observed Value in Reticulocyte Count (count/mL)</measure>
    <time_frame>Up to approximately 8 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Observed Value in Free Hemoglobin and Haptoglobin (mg/dL)</measure>
    <time_frame>Up to approximately 8 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Reticulocyte Count (count/mL)</measure>
    <time_frame>Baseline up to Week 25</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Absolute Change in Free Hemoglobin and Haptoglobin (mg/dL)</measure>
    <time_frame>Baseline up to Week 25</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">190</enrollment>
  <condition>Paroxysmal Nocturnal Hemoglobinuria</condition>
  <arm_group>
    <arm_group_label>Arm A (Crovalimab)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a loading series of crovalimab comprised of an intravenous (IV) dose on Day 1, followed by weekly crovalimab subcutaneous (SC) doses for 4 weeks on Week 1 Day 2, then on Weeks 2, 3, and 4. Maintenance SC dosing will begin at Week 5 and will continue Q4W (every 4 weeks) thereafter for a total of 24 weeks of study treatment. After 24 weeks of crovalimab treatment, participants who derive benefit from the drug may continue to receive crovalimab.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B (Eculizumab)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive an approved maintenance dose of eculizumab starting on Day 1 and Q2W (every 2 weeks) thereafter for a total of 24 weeks of study treatment. After 24 weeks of study eculizumab treatment, participants will have the option to switch to crovalimab or to discontinue from the study after completion of 10 weeks of safety follow-up.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm C (Crovalimab) (Exploratory)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a loading series of Crovalimab comprised of an IV dose on Week 1 Day 1, followed by weekly crovalimab SC doses for 4 weeks on Week 1 (Day 2) then on Weeks 2, 3, and 4. Maintenance SC dosing will begin at Week 5 and will be administered Q4W thereafter. After 24 weeks of crovalimab treatment, participants who derive benefit from the drug may continue to receive crovalimab.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Crovalimab</intervention_name>
    <description>Crovalimab will be administered at a dose of 1000 mg IV (for participants with body weight between 40 and 100kg) or 1500 mg IV (for participants with body weight &gt;=100kg) on Week 1 Day 1. On Week 1 Day 2 and on Weeks 2, 3 and 4, it will be administered at a dose of 340 mg SC. For Week 5 and Q4W thereafter, it will be administered at a dose of 680 mg SC (for participants with body weight between 40 and 100kg) or 1020 mg SC (for participants with body weight &gt;=100kg). Dosing schedule will be as described above.</description>
    <arm_group_label>Arm A (Crovalimab)</arm_group_label>
    <arm_group_label>Arm C (Crovalimab) (Exploratory)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Eculizumab</intervention_name>
    <description>Eculizumab will be administered at a dose of 900 mg every 2 weeks, as per the dosing schedule described above.</description>
    <arm_group_label>Arm B (Eculizumab)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body weight &gt;= 40 kg at screening.&#xD;
&#xD;
          -  Treated with eculizumab or ravulizumab for PNH for at least 3 months prior to Day 1.&#xD;
&#xD;
          -  Lactate Dehydrogenase Levels =&lt; 2x the upper limit of normal (ULN) at screening.&#xD;
&#xD;
          -  Willingness and ability to comply with all study visits and procedures.&#xD;
&#xD;
          -  Documented diagnosis of PNH, confirmed by high sensitivity flow cytometry.&#xD;
&#xD;
          -  Vaccination against Neisseria meningitidis serotypes A, C, W, and Y &lt; 3 years prior to&#xD;
             initiation of study treatment; or, if not previously done, vaccination administered no&#xD;
             later than one week after the first drug administration.&#xD;
&#xD;
          -  Women of childbearing potential: agreement to remain abstinent (refrain from&#xD;
             heterosexual intercourse) or use contraception during the treatment period and for&#xD;
             10.5 months after the final dose of crovalimab or for 3 months after the final dose of&#xD;
             eculizumab (or longer if required by the local product label).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of allogeneic bone marrow transplantation.&#xD;
&#xD;
          -  History of myelodysplastic syndrome with Revised International Prognostic Scoring&#xD;
             System (IPSS-R) prognostic risk categories of intermediate, high and very high.&#xD;
&#xD;
          -  Pregnant or breastfeeding, or intending to become pregnant during the study, within&#xD;
             10.5 months after the final dose of crovalimab, or 3 months after the final dose of&#xD;
             eculizumab (or longer if required by the local product label).&#xD;
&#xD;
          -  Participation in another interventional treatment study with an investigational agent&#xD;
             or use of any experimental therapy within 28 days of screening or within 5 half-lives&#xD;
             of that investigational product, whichever was greater: participants enrolled in an&#xD;
             eculizumab or ravulizumab interventional study are eligible provided they fulfill&#xD;
             eligibility (e.g., are willing and able to comply with the study assessments) and stop&#xD;
             their participation in current trial before randomisation/enrolment.&#xD;
&#xD;
          -  Positive for Active Hepatitis B and C infection (HBV/HCV).&#xD;
&#xD;
          -  Concurrent disease, treatment, procedure, or surgery or abnormality in clinical&#xD;
             laboratory tests that could interfere with the conduct of the study, may pose any&#xD;
             additional risk for the participant, or would, in the opinion of the investigator,&#xD;
             preclude the participant's safe participation in and completion of the study.&#xD;
&#xD;
          -  History of or ongoing cryoglobulinemia at screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Reference Study ID Number: BO42161 https://forpatients.roche.com/</last_name>
    <phone>888-662-6728 (U.S. and Canada)</phone>
    <email>global-roche-genentech-trials@gene.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Oncology Institute of Hope and Innovation</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>David Geffen School of Medicine UCLA</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Indiana Blood &amp; Marrow Transplantation, LLC</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46237</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Carolinas Healthcare System</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28208</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nationwide Children's Hospital; Dept. of Pulmonology</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Cook Childrens Medical Center</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center at San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Liverpool Hospital</name>
      <address>
        <city>Liverpool</city>
        <state>New South Wales</state>
        <zip>2170</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Westmead Hospital</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Royal Perth Hospital</name>
      <address>
        <city>Perth</city>
        <state>Western Australia</state>
        <zip>6000</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Cliniques Universitaires Saint-Luc; Pharmacy</name>
      <address>
        <city>Bruxelles</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>AZ Delta Campus Westlaan</name>
      <address>
        <city>Roeselare</city>
        <zip>8800</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU UCL Namur / site Godinne</name>
      <address>
        <city>Yvoir</city>
        <zip>B5530</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Walter Cantidio - UFC</name>
      <address>
        <city>Fortaleza</city>
        <state>CE</state>
        <zip>60430-370</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nucleo de Pesquisa Clinica do Hospital da Crianca</name>
      <address>
        <city>Brasilia</city>
        <state>DF</state>
        <zip>70684-831</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chronos Pesquisa Clinica</name>
      <address>
        <city>Taguatinga</city>
        <state>DF</state>
        <zip>72145-450</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Elo Clinical Research</name>
      <address>
        <city>Maringa</city>
        <state>PA</state>
        <zip>87015-200</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Centro Integrado de Oncologia de Curitiba</name>
      <address>
        <city>Curitiba</city>
        <state>PR</state>
        <zip>80810-050</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hrpc - Health Clinical Research Representation - Eireli</name>
      <address>
        <city>Canoas</city>
        <state>RS</state>
        <zip>92010-170</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Santa Casa de Misericordia de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90020-090</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital de Clínicas de Porto Alegre X</name>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Instituto Joinvilense de Hematologia E Oncologia</name>
      <address>
        <city>Joinville</city>
        <state>SC</state>
        <zip>89201-260</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fundação Doutor Amaral Carvalho</name>
      <address>
        <city>JAU</city>
        <state>SP</state>
        <zip>17210-120</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital das Clínicas FMRP-USP</name>
      <address>
        <city>Ribeirao Preto</city>
        <state>SP</state>
        <zip>14048-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>*X*CEPHO - Centro de Estudos e Pesquisas em Hematologia e Oncologia</name>
      <address>
        <city>Santo André</city>
        <state>SP</state>
        <zip>09060-650</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Sírio-Libanês</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>01308-050</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Paulistano</name>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>01321-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Beneficencia Portuguesa de Sao Paulo</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>01321-00</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CISSS Chaudière-Appalaches</name>
      <address>
        <city>Levis</city>
        <state>Quebec</state>
        <zip>G6V 3Z1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fundacion Santa Fe de Bogota</name>
      <address>
        <city>Bogota</city>
        <zip>110111</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Ustav hematologie a krevni transfuze</name>
      <address>
        <city>Praha</city>
        <zip>128 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>North Estonia Medical Centre Foundation</name>
      <address>
        <city>Tallinn</city>
        <zip>13419</zip>
        <country>Estonia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital Claude Huriez - CHU Lille</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Institut Paoli Calmette; Service d'Hématologie Clinique</name>
      <address>
        <city>Marseille</city>
        <zip>13273</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU Rennes - Hopital Pontchaillou; Service d'Hémostase Bioclinique</name>
      <address>
        <city>Rennes cedex 9</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Aachen AOeR</name>
      <address>
        <city>Aachen</city>
        <zip>52074</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum</name>
      <address>
        <city>Essen</city>
        <zip>45147</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>ELBLANDKLINIKUM Riesa</name>
      <address>
        <city>Riesa</city>
        <zip>01589</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Ulm</name>
      <address>
        <city>Ulm</city>
        <zip>89081</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University General Hospital of Alexandroupolis</name>
      <address>
        <city>Alexandroupolis</city>
        <zip>681 00</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>General Hospital of Athens LAIKO</name>
      <address>
        <city>Athens</city>
        <zip>115 27</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Attikon University General Hospital</name>
      <address>
        <city>Chaidari</city>
        <zip>124 62</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University General Hospital of Larissa</name>
      <address>
        <city>Larissa</city>
        <zip>412 21</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>General Hospital of Thessaloniki G. Papanikolaou</name>
      <address>
        <city>Thessaloniki</city>
        <zip>57010</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Chinese University of Hong Kong</name>
      <address>
        <city>Shatin</city>
        <zip>123456</zip>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Semmelweis Egyetem</name>
      <address>
        <city>Budapest</city>
        <zip>1088</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>St James's Hospital</name>
      <address>
        <city>Dublin</city>
        <zip>8</zip>
        <country>Ireland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera San Giuseppe Moscati</name>
      <address>
        <city>Avellino</city>
        <state>Campania</state>
        <zip>83100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Azienda Unita Sanitaria Locale- Ravenna</name>
      <address>
        <city>Ravenna</city>
        <state>Emilia-Romagna</state>
        <zip>48100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</name>
      <address>
        <city>Roma</city>
        <state>Lazio</state>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS CA? Granda Ospedale Maggiore Policlinico</name>
      <address>
        <city>Milano</city>
        <state>Molise</state>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Città della Salute e della Scienza di Torino</name>
      <address>
        <city>Torino</city>
        <state>Piemonte</state>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele</name>
      <address>
        <city>Catania</city>
        <state>Sicilia</state>
        <zip>95123</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Careggi</name>
      <address>
        <city>Florence</city>
        <state>Toscana</state>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fujita Health University Hospital</name>
      <address>
        <city>Aichi</city>
        <zip>470-1192</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fukushima Medical University Hospital</name>
      <address>
        <city>Fukushima</city>
        <zip>960-1295</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sapporo Medical University Hospital</name>
      <address>
        <city>Hokkaido</city>
        <zip>060-8543</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Kobe University Hospital; Medical Oncology and Hematology</name>
      <address>
        <city>Hyogo</city>
        <zip>650-0017</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tokushukai Takasago Seibu Hospital</name>
      <address>
        <city>Hyogo</city>
        <zip>676-0812</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Tsukuba Hospital</name>
      <address>
        <city>Ibaraki</city>
        <zip>305-8576</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Ishikawa Prefectural Central Hospital</name>
      <address>
        <city>Ishikawa</city>
        <zip>920-8530</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tokai University Hospital</name>
      <address>
        <city>Kanagawa</city>
        <zip>259-1193</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Mie University Hospital</name>
      <address>
        <city>Mie</city>
        <zip>514-8507</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Japanese Red Cross Society Suwa Hospital</name>
      <address>
        <city>Nagano</city>
        <zip>392-8510</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nagasaki University Hospital</name>
      <address>
        <city>Nagasaki</city>
        <zip>852-8501</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sasebo City General Hospital</name>
      <address>
        <city>Nagasaki</city>
        <zip>857-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Okayama Medical Center</name>
      <address>
        <city>Okayama</city>
        <zip>701-1192</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Osaka University Hospital</name>
      <address>
        <city>Osaka</city>
        <zip>565-0871</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Iwate Prefectural Isawa Hospital</name>
      <address>
        <city>Oshu</city>
        <zip>023-0864</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>NTT Medical Center Tokyo</name>
      <address>
        <city>Tokyo</city>
        <zip>141-8625</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical University Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>160-0023</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Toyama Prefectual Central Hospital</name>
      <address>
        <city>Toyama</city>
        <zip>930-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Severance Hospital; Yonsei University Health System</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ulsan University Hospital</name>
      <address>
        <city>Ulsan</city>
        <zip>44033</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Amsterdam UMC, Locatie AMC</name>
      <address>
        <city>Amsterdam</city>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Szpital Uniwersytecki nr2 im. dr J. Biziela</name>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-168</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii</name>
      <address>
        <city>Gdansk</city>
        <zip>80-952</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>SPZOZ Szpital Uniw W Krakowie</name>
      <address>
        <city>Krakow</city>
        <zip>31-501</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Samodzielny Publiczny Szpital Kliniczny nr 1</name>
      <address>
        <city>Lublin</city>
        <zip>20-081</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centrum Medyczne Pratia Poznan</name>
      <address>
        <city>Skórzewo</city>
        <zip>60-185</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>MTZ Clinical Research Powered by Pratia</name>
      <address>
        <city>Warszawa</city>
        <zip>02-172</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centro Hospitalar do Porto - Hospital de Santo António</name>
      <address>
        <city>Porto</city>
        <zip>4099-001</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>King Faisal Specialist Hospital &amp; Research Center</name>
      <address>
        <city>Riyadh</city>
        <zip>12713</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>National University Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>117599</zip>
        <country>Singapore</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>ICO Badalona - Hospital Universitari Germans Trias i Pujol; Hematologia Clinica</name>
      <address>
        <city>Badalona</city>
        <state>Barcelona</state>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Sant Joan De Deu</name>
      <address>
        <city>Esplugues De Llobregas</city>
        <state>Barcelona</state>
        <zip>08950</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario de Santiago.</name>
      <address>
        <city>Santiago de Compostela</city>
        <state>LA Coruña</state>
        <zip>5ºA</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Gran Canaria</name>
      <address>
        <city>Las Palmas de Gran Canaria</city>
        <state>LAS Palmas</state>
        <zip>35019</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital de Basurto</name>
      <address>
        <city>Bilbao</city>
        <state>Vizcaya</state>
        <zip>48013</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital U. Central de Asturias</name>
      <address>
        <city>Asturias</city>
        <zip>33011</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital San Pedro de Alcantara</name>
      <address>
        <city>Caceres</city>
        <zip>10003</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Marañon</name>
      <address>
        <city>Madrid</city>
        <zip>28007</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Clinico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Regional Universitario de Malaga</name>
      <address>
        <city>Malaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario de Salamanca</name>
      <address>
        <city>Salamanca</city>
        <zip>37007</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocio</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario de Toledo</name>
      <address>
        <city>Toledo</city>
        <zip>45004</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari i Politecnic La Fe de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Miguel Servet</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Akademiska Sjukhuset</name>
      <address>
        <city>Uppsala</city>
        <zip>751 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Changhua Christian Hospital</name>
      <address>
        <city>Chang Hua</city>
        <zip>500</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hualien Tzu Chi Hospital; Hematology and oncology</name>
      <address>
        <city>Hualien City</city>
        <zip>97002</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chi Mei Medical Center Liou Ying Campus</name>
      <address>
        <city>Liuying Township</city>
        <zip>736</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>National Taiwan Universtiy Hospital; Division of Hematology</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>MacKay Memorial Hospital; Hematology and oncology</name>
      <address>
        <city>Zhongshan Dist.</city>
        <zip>10449</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Hacettepe University Medical Faculty; Neurology</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Gaziantep University Medical Faculty Sahinbey Educational Research Hospital; Hematology</name>
      <address>
        <city>Gaziantep</city>
        <zip>27310</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Istanbul University Istanbul Medical Faculty; Neurology</name>
      <address>
        <city>Istanbul</city>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Marmara University Pendik Training and Research Hospital, Hematology Department</name>
      <address>
        <city>Istanbul</city>
        <zip>34300</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ege University Medical Faculty; Hematology</name>
      <address>
        <city>Izmir</city>
        <zip>35040</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ondokuz Mayis Univ. Med. Fac.</name>
      <address>
        <city>Samsun</city>
        <zip>55139</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>King'S College Hospital; Haematology</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Colombia</country>
    <country>Czechia</country>
    <country>Estonia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Greece</country>
    <country>Hong Kong</country>
    <country>Hungary</country>
    <country>Ireland</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Saudi Arabia</country>
    <country>Singapore</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>Taiwan</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Israel</country>
    <country>Mexico</country>
    <country>Slovakia</country>
  </removed_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>September 4, 2023</last_update_submitted>
  <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemoglobinuria</mesh_term>
    <mesh_term>Hemoglobinuria, Paroxysmal</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Eculizumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04432584
org study id: BO42161
secondary id: 2020-000597-26
nct id: NCT04432584
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
A study designed to evaluate the safety of crovalimab with eculizumab in participants with
      PNH currently treated with complement inhibitors. This study will enroll approximately 190
      participants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants with Adverse Events (AEs) and by Severity
time frame: Up to approximately 8 years
description: Determined according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, Version 5 (CTCAE v5).
measure: Percentage of Participants with Injection- Site Reactions, Infusion-Related Reactions, Hypersensitivity and Infections (including Meningococcal Meningitis)
time frame: Up to approximately 8 years
measure: Percentage of Participants with Adverse Events (AEs) Leading to Study Drug Discontinuation
time frame: Up to approximately 8 years
measure: Percentage of Participants with Clinical Manifestations of Drug-Target-Drug Complex (DTDC) Formation Amongst Those Participants who Switched to Crovalimab Treatment from Eculizumab Treatment or Ravulizumab Treatment
time frame: Up to approximately 8 years
measure: Serum Concentrations of Crovalimab or Eculizumab Over Time
time frame: Up to approximately 8 years
measure: Serum Concentrations of Ravulizumab at the time of Crovalimab Initiation
time frame: Baseline
measure: Percentage of Participants with Anti-Crovalimab Antibodies
time frame: Up to approximately 8 years
measure: Change in Pharmacodynamic (PD) Biomarker Complement Activity (CH50) Over Time
time frame: Up to approximately 8 years
measure: Change Over Time in Free C5 Concentration in Crovalimab-Treated Participants
time frame: Up to approximately 8 years
measure: Observed Value in Reticulocyte Count (count/mL)
time frame: Up to approximately 8 years
measure: Observed Value in Free Hemoglobin and Haptoglobin (mg/dL)
time frame: Up to approximately 8 years
measure: Change in Reticulocyte Count (count/mL)
time frame: Baseline up to Week 25
measure: Absolute Change in Free Hemoglobin and Haptoglobin (mg/dL)
time frame: Baseline up to Week 25
arm group label: Arm A (Crovalimab)
arm group type: Experimental
description: Participants will receive a loading series of crovalimab comprised of an intravenous (IV) dose on Day 1, followed by weekly crovalimab subcutaneous (SC) doses for 4 weeks on Week 1 Day 2, then on Weeks 2, 3, and 4. Maintenance SC dosing will begin at Week 5 and will continue Q4W (every 4 weeks) thereafter for a total of 24 weeks of study treatment. After 24 weeks of crovalimab treatment, participants who derive benefit from the drug may continue to receive crovalimab.
arm group label: Arm B (Eculizumab)
arm group type: Active Comparator
description: Participants will receive an approved maintenance dose of eculizumab starting on Day 1 and Q2W (every 2 weeks) thereafter for a total of 24 weeks of study treatment. After 24 weeks of study eculizumab treatment, participants will have the option to switch to crovalimab or to discontinue from the study after completion of 10 weeks of safety follow-up.
arm group label: Arm C (Crovalimab) (Exploratory)
arm group type: Experimental
description: Participants will receive a loading series of Crovalimab comprised of an IV dose on Week 1 Day 1, followed by weekly crovalimab SC doses for 4 weeks on Week 1 (Day 2) then on Weeks 2, 3, and 4. Maintenance SC dosing will begin at Week 5 and will be administered Q4W thereafter. After 24 weeks of crovalimab treatment, participants who derive benefit from the drug may continue to receive crovalimab.
intervention type: Drug
intervention name: Crovalimab
description: Crovalimab will be administered at a dose of 1000 mg IV (for participants with body weight between 40 and 100kg) or 1500 mg IV (for participants with body weight >=100kg) on Week 1 Day 1. On Week 1 Day 2 and on Weeks 2, 3 and 4, it will be administered at a dose of 340 mg SC. For Week 5 and Q4W thereafter, it will be administered at a dose of 680 mg SC (for participants with body weight between 40 and 100kg) or 1020 mg SC (for participants with body weight >=100kg). Dosing schedule will be as described above.
arm group label: Arm A (Crovalimab)
arm group label: Arm C (Crovalimab) (Exploratory)
intervention type: Drug
intervention name: Eculizumab
description: Eculizumab will be administered at a dose of 900 mg every 2 weeks, as per the dosing schedule described above.
arm group label: Arm B (Eculizumab)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
last name: Reference Study ID Number: BO42161 https://forpatients.roche.com/
phone: 888-662-6728 (U.S. and Canada)
email: global-roche-genentech-trials@gene.com
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Withdrawn
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
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status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
facility: 
status: Withdrawn
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status: Recruiting
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status: Recruiting
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status: Withdrawn
facility: 
status: Active, not recruiting
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status: Recruiting
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status: Active, not recruiting
facility: 
status: Active, not recruiting
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status: Recruiting
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status: Recruiting
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status: Active, not recruiting
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status: Recruiting
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status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Completed
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
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status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Withdrawn
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Australia
country: Belgium
country: Brazil
country: Canada
country: Colombia
country: Czechia
country: Estonia
country: France
country: Germany
country: Greece
country: Hong Kong
country: Hungary
country: Ireland
country: Italy
country: Japan
country: Korea, Republic of
country: Netherlands
country: Poland
country: Portugal
country: Saudi Arabia
country: Singapore
country: Spain
country: Sweden
country: Taiwan
country: Turkey
country: United Kingdom
country: United States
country: Israel
country: Mexico
country: Slovakia
responsible party type: Sponsor
mesh term: Hemoglobinuria
mesh term: Hemoglobinuria, Paroxysmal
mesh term: Eculizumab
sharing ipd: Yes
ipd description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).