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Study to Assess Safety, Tolerability and Efficacy of Incremental Doses of MGB-BP-3 in Patients With CDAD

Sponsor
MGB Biopharma Limited (Industry)
Overall Status
Completed
CT.gov ID
NCT03824795
Collaborator
Syneos Health (Other)
34
Enrollment
9
Locations
3
Arms
13.8
Actual Duration (Months)
3.8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
34 participants
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.This is an open-label study with 3 sequential groups of 10 patients with CDAD with a staggered start.
Masking:
None (Open Label)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Feb 7, 2019
Actual Primary Completion Date :
Apr 3, 2020
Actual Study Completion Date :
Apr 3, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group 1: 125mg b.i.d. for 10 days

Patients will be administered an oral dose of 125mg b.i.d. MGB-BP-3 for 10 days (Day 1 to Day 10).

Drug: MGB-BP-3
MGB-BP-3
Other Names:
  • No other names - not applicable

    		•
    Active Comparator: Group 2: 250mg b.i.d. for 10 days

    Patients will be administered an oral dose of 250mg b.i.d. MGB-BP-3 for 10 days (Day 1 to Day 10).

    Drug: MGB-BP-3
    MGB-BP-3
    Other Names:
  • No other names - not applicable

    		•
    Active Comparator: Group 3: 500mg b.i.d. for 10 days

    Patients will be administered an oral dose of 500mg b.i.d. MGB-BP-3 for 10 days (Day 1 to Day 10).

    Drug: MGB-BP-3
    MGB-BP-3
    Other Names:
  • No other names - not applicable

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with treatment-related adverse events assessed by the Investigator, as per CTCAE v.5.0. [40 days]

      Incidence of treatment emergent adverse events (Safety and Tolerability of up to 3 incremental doses of MGB-BP-3 in patients with CDAD).

    2. Initial cure rate at 12 days post initiation of therapy. [12 days]

      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.

    Secondary Outcome Measures

    1. CDAD Recurrence [Up to 8 weeks]

      Recurrence of CDAD within 4 weeks (8 weeks optional) post end of treatment.

    2. Peak plasma concentration (Cmax). [10 days]

      Days 1, 5 and 10.

    3. Time to peak plasma concentration (Tmax). [10 days]

      Days 1, 5 and 10.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Main Inclusion Criteria:

    1. Age 18 years or older of any gender.

    2. Inpatients and/or outpatients who are able to attend all scheduled visits.

    3. Patients with the first episode or the first recurrence of mild or moderate CDAD.

    4. Confirmed diagnosis of mild or moderate CDAD as defined by the Infectious Diseases Society of America/Society for Healthcare Epidemiology of America guidelines.

    Main Exclusion Criteria:

    1. Patients with severe complicated CDAD (including hypotension or shock, ileus, megacolon, pseudomembranous colitis).

    2. A white blood cell count higher than 15,000 cells/mL.

    3. A serum creatinine level greater than or equal to 1.5 times ULN.

    4. Elevated liver enzymes alanine aminotransferase and aspartate aminotransferase greater than ULN.

    5. Inflammatory bowel disease (ulcerative colitis or Crohn's disease), microscopic colitis, or irritable bowel syndrome with chronic diarrhea.

    6. Any other non-C difficile diarrhea.

    7. Received treatment with a fecal transplant within 7 days and/or is anticipated to receive a fecal transplant during the study.

    8. Major gastrointestinal surgery (ie, significant bowel resection) within 3 months of enrollment (does not include appendectomy or cholecystectomy).

    9. Received laxatives within the previous 48 hours.

    10. Pregnant or lactating women.

    11. Prior (within 180 days of Screening) or current use of anti-toxin antibodies.

    12. Have received a vaccine against C difficile.

    13. Any condition for which, in the opinion of the investigator, the treatment may pose a health risk to the patient.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Florida International Medical Research Miami Florida United States 33155
    2 Omega Research Maitland LLC Orlando Florida United States 32810
    3 Snake River Research PLLC Idaho Falls Idaho United States 83404
    4 Ochsner Clinic Foundation Infectious Disease Research New Orleans Louisiana United States 70121
    5 Anne Arundel Medical Centre Annapolis Maryland United States 21401
    6 Mercury Street Medical Group PLLC Butte Montana United States 59701
    7 Biopharma Informatic LLC Houston Texas United States 77084
    8 Verity Research Inc. Fairfax Virginia United States 22031
    9 Foothills Medical Centre Calgary Alberta Canada T2N 2T9

    Sponsors and Collaborators

    • MGB Biopharma Limited
    • Syneos Health

    Investigators

    • Study Director: Miroslav Ravic, MD, MGB Biopharma Ltd.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MGB Biopharma Limited
    ClinicalTrials.gov Identifier:
    NCT03824795
    Other Study ID Numbers:
    • 1011464
    • 2015-000489-73
    • 129507
    • MGB-BP-3-201
    First Posted:
    Jan 31, 2019
    Last Update Posted:
    Apr 15, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by MGB Biopharma Limited
    Clostridium difficile
    CDAD
    MGB-BP-3
    Novel anti-infective
    Efficacy
    Tolerability
    Safety
    Phase IIa
    Additional relevant MeSH terms:
    Clostridium Infections

    Study Results

    No Results Posted as of Apr 15, 2020