<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/NCT03824795</url>
  </required_header>
  <id_info>
    <org_study_id>1011464</org_study_id>
    <secondary_id>2015-000489-73</secondary_id>
    <secondary_id>129507</secondary_id>
    <secondary_id>MGB-BP-3-201</secondary_id>
    <nct_id>NCT03824795</nct_id>
  </id_info>
  <brief_title>Study to Assess Safety, Tolerability and Efficacy of Incremental Doses of MGB-BP-3 in Patients With CDAD</brief_title>
  <official_title>An Exploratory, Open Labelled, Phase IIa Study to Assess Safety, Tolerability and Efficacy of Incremental Doses of MGB-BP-3 in Patients With Clostridium Difficile-associated Diarrhea (CDAD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MGB Biopharma Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Syneos Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>MGB Biopharma Limited</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this Phase IIa study is to assess the safety, tolerability, and efficacy of&#xD;
      incremental doses of MGB-BP-3 in patients with Clostridium difficile-associated diarrhea&#xD;
      (CDAD).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an exploratory, Phase IIa, open-label study assessing the safety, tolerability, and&#xD;
      efficacy of incremental doses of MGB-BP-3 with 3 sequential groups of 10 patients with CDAD.&#xD;
      Patients will be administered an oral dose of MGB-BP-3 for 10 days (Day 1 to Day 10). At the&#xD;
      end of the treatment period, patients will be followed for up to 8 weeks to assess the&#xD;
      incidence of disease recurrence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 7, 2019</start_date>
  <completion_date type="Actual">April 3, 2020</completion_date>
  <primary_completion_date type="Actual">April 3, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>This is an open-label study with 3 sequential groups of 10 patients with CDAD with a staggered start.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with treatment-related adverse events assessed by the Investigator, as per CTCAE v.5.0.</measure>
    <time_frame>40 days</time_frame>
    <description>Incidence of treatment emergent adverse events (Safety and Tolerability of up to 3 incremental doses of MGB-BP-3 in patients with CDAD).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Initial cure rate at 12 days post initiation of therapy.</measure>
    <time_frame>12 days</time_frame>
    <description>Initial clinical cure is defined as resolution of diarrhea (&lt;3 bowel movements with unformed stools within 24 hours [Type 5, 6, or 7 bowel movement on the Bristol Stool Chart] for patients for 2 consecutive days), maintained for the subsequent duration of therapy (1 day of exacerbation and then return to the resolved state is acceptable), with no further requirement for CDAD therapy, assessed by EOT and sustained for 2 days after the end of the 10-day initial treatment course.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CDAD Recurrence</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Recurrence of CDAD within 4 weeks (8 weeks optional) post end of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak plasma concentration (Cmax).</measure>
    <time_frame>10 days</time_frame>
    <description>Days 1, 5 and 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to peak plasma concentration (Tmax).</measure>
    <time_frame>10 days</time_frame>
    <description>Days 1, 5 and 10.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Clostridium Difficile Infection</condition>
  <arm_group>
    <arm_group_label>Group 1: 125mg b.i.d. for 10 days</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be administered an oral dose of 125mg b.i.d. MGB-BP-3 for 10 days (Day 1 to Day 10).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: 250mg b.i.d. for 10 days</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be administered an oral dose of 250mg b.i.d. MGB-BP-3 for 10 days (Day 1 to Day 10).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3: 500mg b.i.d. for 10 days</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be administered an oral dose of 500mg b.i.d. MGB-BP-3 for 10 days (Day 1 to Day 10).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MGB-BP-3</intervention_name>
    <description>MGB-BP-3</description>
    <arm_group_label>Group 1: 125mg b.i.d. for 10 days</arm_group_label>
    <arm_group_label>Group 2: 250mg b.i.d. for 10 days</arm_group_label>
    <arm_group_label>Group 3: 500mg b.i.d. for 10 days</arm_group_label>
    <other_name>No other names - not applicable</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Main Inclusion Criteria:&#xD;
&#xD;
          1. Age 18 years or older of any gender.&#xD;
&#xD;
          2. Inpatients and/or outpatients who are able to attend all scheduled visits.&#xD;
&#xD;
          3. Patients with the first episode or the first recurrence of mild or moderate CDAD.&#xD;
&#xD;
          4. Confirmed diagnosis of mild or moderate CDAD as defined by the Infectious Diseases&#xD;
             Society of America/Society for Healthcare Epidemiology of America guidelines.&#xD;
&#xD;
        Main Exclusion Criteria:&#xD;
&#xD;
          1. Patients with severe complicated CDAD (including hypotension or shock, ileus,&#xD;
             megacolon, pseudomembranous colitis).&#xD;
&#xD;
          2. A white blood cell count higher than 15,000 cells/mL.&#xD;
&#xD;
          3. A serum creatinine level greater than or equal to 1.5 times ULN.&#xD;
&#xD;
          4. Elevated liver enzymes alanine aminotransferase and aspartate aminotransferase greater&#xD;
             than ULN.&#xD;
&#xD;
          5. Inflammatory bowel disease (ulcerative colitis or Crohn's disease), microscopic&#xD;
             colitis, or irritable bowel syndrome with chronic diarrhea.&#xD;
&#xD;
          6. Any other non-C difficile diarrhea.&#xD;
&#xD;
          7. Received treatment with a fecal transplant within 7 days and/or is anticipated to&#xD;
             receive a fecal transplant during the study.&#xD;
&#xD;
          8. Major gastrointestinal surgery (ie, significant bowel resection) within 3 months of&#xD;
             enrollment (does not include appendectomy or cholecystectomy).&#xD;
&#xD;
          9. Received laxatives within the previous 48 hours.&#xD;
&#xD;
         10. Pregnant or lactating women.&#xD;
&#xD;
         11. Prior (within 180 days of Screening) or current use of anti-toxin antibodies.&#xD;
&#xD;
         12. Have received a vaccine against C difficile.&#xD;
&#xD;
         13. Any condition for which, in the opinion of the investigator, the treatment may pose a&#xD;
             health risk to the patient.&#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>Miroslav Ravic, MD</last_name>
    <role>Study Director</role>
    <affiliation>MGB Biopharma Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Florida International Medical Research</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omega Research Maitland LLC</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32810</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Snake River Research PLLC</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Clinic Foundation Infectious Disease Research</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anne Arundel Medical Centre</name>
      <address>
        <city>Annapolis</city>
        <state>Maryland</state>
        <zip>21401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercury Street Medical Group PLLC</name>
      <address>
        <city>Butte</city>
        <state>Montana</state>
        <zip>59701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Biopharma Informatic LLC</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Verity Research Inc.</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foothills Medical Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 2T9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>April 14, 2020</last_update_submitted>
  <last_update_submitted_qc>April 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Clostridium difficile</keyword>
  <keyword>CDAD</keyword>
  <keyword>MGB-BP-3</keyword>
  <keyword>Novel anti-infective</keyword>
  <keyword>Efficacy</keyword>
  <keyword>Tolerability</keyword>
  <keyword>Safety</keyword>
  <keyword>Phase IIa</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clostridium Infections</mesh_term>
  </condition_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/NCT03824795
org study id: 1011464
secondary id: 2015-000489-73
secondary id: 129507
secondary id: MGB-BP-3-201
nct id: NCT03824795
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The objective of this Phase IIa study is to assess the safety, tolerability, and efficacy of
      incremental doses of MGB-BP-3 in patients with Clostridium difficile-associated diarrhea
      (CDAD).
This is an exploratory, Phase IIa, open-label study assessing the safety, tolerability, and
      efficacy of incremental doses of MGB-BP-3 with 3 sequential groups of 10 patients with CDAD.
      Patients will be administered an oral dose of MGB-BP-3 for 10 days (Day 1 to Day 10). At the
      end of the treatment period, patients will be followed for up to 8 weeks to assess the
      incidence of disease recurrence.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: This is an open-label study with 3 sequential groups of 10 patients with CDAD with a staggered start.
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with treatment-related adverse events assessed by the Investigator, as per CTCAE v.5.0.
time frame: 40 days
description: Incidence of treatment emergent adverse events (Safety and Tolerability of up to 3 incremental doses of MGB-BP-3 in patients with CDAD).
measure: Initial cure rate at 12 days post initiation of therapy.
time frame: 12 days
description: Initial clinical cure is defined as resolution of diarrhea (<3 bowel movements with unformed stools within 24 hours [Type 5, 6, or 7 bowel movement on the Bristol Stool Chart] for patients for 2 consecutive days), maintained for the subsequent duration of therapy (1 day of exacerbation and then return to the resolved state is acceptable), with no further requirement for CDAD therapy, assessed by EOT and sustained for 2 days after the end of the 10-day initial treatment course.
measure: CDAD Recurrence
time frame: Up to 8 weeks
description: Recurrence of CDAD within 4 weeks (8 weeks optional) post end of treatment.
measure: Peak plasma concentration (Cmax).
time frame: 10 days
description: Days 1, 5 and 10.
measure: Time to peak plasma concentration (Tmax).
time frame: 10 days
description: Days 1, 5 and 10.
arm group label: Group 1: 125mg b.i.d. for 10 days
arm group type: Active Comparator
description: Patients will be administered an oral dose of 125mg b.i.d. MGB-BP-3 for 10 days (Day 1 to Day 10).
arm group label: Group 2: 250mg b.i.d. for 10 days
arm group type: Active Comparator
description: Patients will be administered an oral dose of 250mg b.i.d. MGB-BP-3 for 10 days (Day 1 to Day 10).
arm group label: Group 3: 500mg b.i.d. for 10 days
arm group type: Active Comparator
description: Patients will be administered an oral dose of 500mg b.i.d. MGB-BP-3 for 10 days (Day 1 to Day 10).
intervention type: Drug
intervention name: MGB-BP-3
description: MGB-BP-3
arm group label: Group 1: 125mg b.i.d. for 10 days
arm group label: Group 2: 250mg b.i.d. for 10 days
arm group label: Group 3: 500mg b.i.d. for 10 days
other name: No other names - not applicable
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Miroslav Ravic, MD
role: Study Director
affiliation: MGB Biopharma Ltd.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Clostridium Infections
sharing ipd: No