<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/NCT03818308</url>
  </required_header>
  <id_info>
    <org_study_id>HepNet-aHCV-V</org_study_id>
    <secondary_id>2018-003474-27</secondary_id>
    <nct_id>NCT03818308</nct_id>
  </id_info>
  <brief_title>Trial for the Treatment of Acute Hepatitis C for 8 Weeks With Sofosbuvir/Velpatasvir</brief_title>
  <official_title>Multicenter Trial for the Treatment of Acute Hepatitis C for 8 Weeks With Sofosbuvir/Velpatasvir Fix Dose combination_The HepNet Acute HCV-V Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hannover Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>HepNet Study House, German Liverfoundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>German Center for Infection Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hannover Medical School</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single arm multicenter pilot study to evaluate the efficacy and safety of treatment&#xD;
      with sofosbuvir (SOF)/velpatasvir (VEL) fix dose combination (FDC) in patients with acute&#xD;
      hepatitis C virus (HCV) infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single arm multicenter pilot study to evaluate the efficacy and safety of treatment&#xD;
      with SOF/VEL FDC for 8 weeks in patients with acute HCV infection as measured by the&#xD;
      proportion of subjects with sustained viral response (undetectable HCV RNA) 12 weeks after&#xD;
      stop of therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 28, 2019</start_date>
  <completion_date type="Actual">June 8, 2021</completion_date>
  <primary_completion_date type="Actual">June 8, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Prospective, open-label, single-arm multicenter, phase II pilot trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of subjects with sustained virological response (undetectable HCV RNA) 12 weeks after discontinuation of therapy</measure>
    <time_frame>12 weeks after discontinuation of therapy</time_frame>
    <description>Measured by the portion of subjects with sustained virological response (undetectable HCV RNA)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean HCV RNA viral load at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after stop of therapy</measure>
    <time_frame>at baseline, after 2 weeks, 4 weeks and 8 weeks of therapy, and 12 weeks after stop of therapy</time_frame>
    <description>Measured by mean HCV RNA viral load</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects who reached ALT normalization (ALT &lt; ULN) after 8 weeks of therapy and 12 weeks after discontinuation of therapy</measure>
    <time_frame>after 8 weeks of therapy, and 12 weeks after discontinuation of therapy</time_frame>
    <description>Measured by the proportion of subjects who reached ALT normalization (ALT &lt; ULN)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of frequency and severity of adverse events (AEs)</measure>
    <time_frame>through study completion, an average of 20 weeks</time_frame>
    <description>Collection of all AEs</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Hepatitis C</condition>
  <condition>Acute Hepatitis C</condition>
  <arm_group>
    <arm_group_label>Sofosbuvir and Velpatasvir</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SOF/VEL FDC film-coated tablet, oral, SOF 400 mg/VEL 100 mg daily, 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sofosbuvir and Velpatasvir</intervention_name>
    <description>All subjects will receive one film-coated tablet of sofosbuvir/velpatasvir (400/100 mg) orally once daily for 8 weeks.</description>
    <arm_group_label>Sofosbuvir and Velpatasvir</arm_group_label>
    <other_name>Epclusa 400 mg/100 mg film-coated tablets</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Willing and able to provide written informed consent&#xD;
&#xD;
          2. Male or female, age &gt; 18 years&#xD;
&#xD;
          3. HCV RNA &gt; 10^3 IU/mL at screening&#xD;
&#xD;
          4. Confirmation of acute HCV infection documented by either:&#xD;
&#xD;
               1. Documented seroconversion to HCV antibody (anti-HCV) positivity within the 4&#xD;
                  months preceding screening&#xD;
&#xD;
               2. Documented conversion to HCV RNA positivity within the 4 months preceding&#xD;
                  screening&#xD;
&#xD;
               3. or known or suspected exposure to HCV within the 4 months preceding screening&#xD;
                  with 10 times elevated serum ALT level at screening or 4 month preceding&#xD;
                  screening without evidence of confounding liver disorders&#xD;
&#xD;
          5. Body mass index (BMI) ≥18 kg/m2&#xD;
&#xD;
          6. Subjects must have the following laboratory parameters at screening:&#xD;
&#xD;
               1. INR ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an&#xD;
                  anticoagulant regimen affecting INR&#xD;
&#xD;
               2. HbA1c ≤ 10%&#xD;
&#xD;
               3. Creatinine clearance (CLcr) ≥ 30 mL/min, as calculated by the Cockcroft-Gault&#xD;
                  equation (using actual body weight)&#xD;
&#xD;
          7. A negative serum pregnancy test is required for female subjects (unless surgically&#xD;
             sterile or women ≥ 54 years of age with cessation for 24 ≥ months of previously&#xD;
             occurring menses). Complete abstinence from intercourse. Periodic abstinence (e.g.,&#xD;
             calendar, ovulation, symptothermal, post-ovulation methods) is not permitted.&#xD;
&#xD;
             Or&#xD;
&#xD;
             Consistent and correct use of 1 of the following methods of birth control listed&#xD;
             below, in addition to a male partner who correctly uses a condom, from the date of&#xD;
             Screening until the end of follow up:&#xD;
&#xD;
               -  intrauterine device (IUD) with a failure rate of &lt; 1% per year&#xD;
&#xD;
               -  female barrier method: cervical cap or diaphragm with spermicidal agent&#xD;
&#xD;
               -  tubal sterilization&#xD;
&#xD;
               -  vasectomy in male partner&#xD;
&#xD;
               -  hormone-containing contraceptive:&#xD;
&#xD;
                    -  implants of levonorgestrel&#xD;
&#xD;
                    -  injectable progesterone&#xD;
&#xD;
                    -  oral contraceptives (either combined or progesterone only)&#xD;
&#xD;
                    -  contraceptive vaginal ring&#xD;
&#xD;
                    -  transdermal contraceptive patch&#xD;
&#xD;
          8. Subject must be able to comply with the dosing instructions for study drug&#xD;
             administration and be able to complete the study schedule of assessments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has been treated with any investigational drug or device within 42 days of the&#xD;
             Screening visit&#xD;
&#xD;
          2. Co-Infection with HIV&#xD;
&#xD;
          3. Clinically-significant illness (other than HCV) or any other major medical disorder&#xD;
             that, in the opinion of the investigator, may interfere with subject treatment,&#xD;
             assessment or compliance with the protocol.&#xD;
&#xD;
          4. Solid organ transplantation&#xD;
&#xD;
          5. Gastrointestinal disorder or post-operative condition that could interfere with the&#xD;
             absorption of the study drug (for example, gastric bypass or severe ulcerative&#xD;
             colitis).&#xD;
&#xD;
          6. Clinical signs of hepatic decompensation (i.e., clinical ascites, encephalopathy or&#xD;
             variceal hemorrhage).&#xD;
&#xD;
          7. Difficulty with blood collection and/or poor venous access for the purposes of&#xD;
             phlebotomy.&#xD;
&#xD;
          8. Psychiatric hospitalization, suicide attempt, and/or a period of disability as a&#xD;
             result of their psychiatric illness within the last 2 years. Subjects with psychiatric&#xD;
             illness that is well-controlled on a stable treatment regimen for at least 12 months&#xD;
             prior to screening or has not required medication in the last 12 months may be&#xD;
             included.&#xD;
&#xD;
          9. Significant drug allergy (such as anaphylaxis or hepatotoxicity).&#xD;
&#xD;
         10. Pregnant or nursing female&#xD;
&#xD;
         11. Clinically-relevant drug or alcohol abuse that significantly impairs patient&#xD;
             compliance. Uncontrolled users of intravenous drugs will not be permitted to enroll in&#xD;
             the study.&#xD;
&#xD;
         12. Clinical relevant (not controlled) liver disease of a non-HCV etiology (e.g.,&#xD;
             hemochromatosis, autoimmune hepatitis, alcoholic liver disease, Wilson's disease, α1&#xD;
             antitrypsin deficiency, cholangitis)&#xD;
&#xD;
         13. Use of any prohibited concomitant medications within 21 days before the Baseline/Day 1&#xD;
             visit. The use of amiodarone is prohibited from 60 days prior to Day 1 through the end&#xD;
             of treatment;&#xD;
&#xD;
         14. Known hypersensitivity to SOF/VEL or formulation excipients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Markus Cornberg, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hannover Medical School, Clinic for Gastroenterology, Hepatology, and Endocrinology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Allgemeinmedizinische und internistische Praxis</name>
      <address>
        <city>Berlin-Friedrichshain</city>
        <zip>10243</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zentrum für Infektiologie Prenzlauer Berg</name>
      <address>
        <city>Berlin</city>
        <zip>10349</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charité Campus Virchow-Klinikum, Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I</name>
      <address>
        <city>Bonn</city>
        <zip>53127</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Essen, Klinik für Gastroenterologie und Hepatologie</name>
      <address>
        <city>Essen</city>
        <zip>45122</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der J.W. Goethe-Universität Frankfurt</name>
      <address>
        <city>Frankfurt</city>
        <zip>60590</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Infektionsmedizinisches Centrum Hamburg (ICH) Study Center</name>
      <address>
        <city>Hamburg</city>
        <zip>20146</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Hamburg-Eppendorf, I. Medizinische Klinik und Poliklinik</name>
      <address>
        <city>Hamburg</city>
        <zip>20246</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover, Innere Medizin, Klinik für Gastroenterologie, Hepatologie und Endokrinologie</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Hohenstaufenring</name>
      <address>
        <city>Köln</city>
        <zip>50674</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Leipzig, Klinik und Poliklinik für Gastroenterologie</name>
      <address>
        <city>Leipzig</city>
        <zip>04103</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum rechts der Isar der TU-München, II Medizinische Klinik und Poliklinik</name>
      <address>
        <city>München</city>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gemeinschaftspraxis - Infectomed</name>
      <address>
        <city>Stuttgart</city>
        <zip>70197</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Würzburg, Medizinische Klinik II, Schwerpunkt Infektiologie</name>
      <address>
        <city>Würzburg</city>
        <zip>97080</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>July 2, 2021</last_update_submitted>
  <last_update_submitted_qc>July 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acute hepatitis C virus (HCV) infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sofosbuvir</mesh_term>
    <mesh_term>Sofosbuvir-velpatasvir drug combination</mesh_term>
    <mesh_term>Velpatasvir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03818308
org study id: HepNet-aHCV-V
secondary id: 2018-003474-27
nct id: NCT03818308
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a single arm multicenter pilot study to evaluate the efficacy and safety of treatment
      with sofosbuvir (SOF)/velpatasvir (VEL) fix dose combination (FDC) in patients with acute
      hepatitis C virus (HCV) infection.
This is a single arm multicenter pilot study to evaluate the efficacy and safety of treatment
      with SOF/VEL FDC for 8 weeks in patients with acute HCV infection as measured by the
      proportion of subjects with sustained viral response (undetectable HCV RNA) 12 weeks after
      stop of therapy.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Prospective, open-label, single-arm multicenter, phase II pilot trial
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of subjects with sustained virological response (undetectable HCV RNA) 12 weeks after discontinuation of therapy
time frame: 12 weeks after discontinuation of therapy
description: Measured by the portion of subjects with sustained virological response (undetectable HCV RNA)
measure: Mean HCV RNA viral load at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after stop of therapy
time frame: at baseline, after 2 weeks, 4 weeks and 8 weeks of therapy, and 12 weeks after stop of therapy
description: Measured by mean HCV RNA viral load
measure: Proportion of subjects who reached ALT normalization (ALT < ULN) after 8 weeks of therapy and 12 weeks after discontinuation of therapy
time frame: after 8 weeks of therapy, and 12 weeks after discontinuation of therapy
description: Measured by the proportion of subjects who reached ALT normalization (ALT < ULN)
measure: Assessment of frequency and severity of adverse events (AEs)
time frame: through study completion, an average of 20 weeks
description: Collection of all AEs
arm group label: Sofosbuvir and Velpatasvir
arm group type: Experimental
description: SOF/VEL FDC film-coated tablet, oral, SOF 400 mg/VEL 100 mg daily, 8 weeks
intervention type: Drug
intervention name: Sofosbuvir and Velpatasvir
description: All subjects will receive one film-coated tablet of sofosbuvir/velpatasvir (400/100 mg) orally once daily for 8 weeks.
arm group label: Sofosbuvir and Velpatasvir
other name: Epclusa 400 mg/100 mg film-coated tablets
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Markus Cornberg, Prof. Dr.
role: Principal Investigator
affiliation: Hannover Medical School, Clinic for Gastroenterology, Hepatology, and Endocrinology
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis
mesh term: Sofosbuvir
mesh term: Sofosbuvir-velpatasvir drug combination
mesh term: Velpatasvir
sharing ipd: No