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

Primary Purpose

Clostridium Difficile Infection

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MGB-BP-3
Sponsored by
MGB Biopharma Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clostridium Difficile Infection focused on measuring Clostridium difficile, CDAD, MGB-BP-3, Novel anti-infective, Efficacy, Tolerability, Safety, Phase IIa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Florida International Medical Research
  • Omega Research Maitland LLC
  • Snake River Research PLLC
  • Ochsner Clinic Foundation Infectious Disease Research
  • Anne Arundel Medical Centre
  • Mercury Street Medical Group PLLC
  • Biopharma Informatic LLC
  • Verity Research Inc.
  • Foothills Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group 1: 125mg b.i.d. for 10 days

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

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

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events assessed by the Investigator, as per CTCAE v.5.0.
Incidence of treatment emergent adverse events (Safety and Tolerability of up to 3 incremental doses of MGB-BP-3 in patients with CDAD).
Initial cure rate at 12 days post initiation of therapy.
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

CDAD Recurrence
Recurrence of CDAD within 4 weeks (8 weeks optional) post end of treatment.
Peak plasma concentration (Cmax).
Days 1, 5 and 10.
Time to peak plasma concentration (Tmax).
Days 1, 5 and 10.

Full Information

First Posted
January 24, 2019
Last Updated
April 14, 2020
Sponsor
MGB Biopharma Limited
Collaborators
Syneos Health
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1. Study Identification

Unique Protocol Identification Number
NCT03824795
Brief Title
Study to Assess Safety, Tolerability and Efficacy of Incremental Doses of MGB-BP-3 in Patients With CDAD
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 7, 2019 (Actual)
Primary Completion Date
April 3, 2020 (Actual)
Study Completion Date
April 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MGB Biopharma Limited
Collaborators
Syneos Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection
Keywords
Clostridium difficile, CDAD, MGB-BP-3, Novel anti-infective, Efficacy, Tolerability, Safety, Phase IIa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Model Description
This is an open-label study with 3 sequential groups of 10 patients with CDAD with a staggered start.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: 125mg b.i.d. for 10 days
Arm Type
Active Comparator
Arm 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 Title
Group 2: 250mg b.i.d. for 10 days
Arm Type
Active Comparator
Arm 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 Title
Group 3: 500mg b.i.d. for 10 days
Arm Type
Active Comparator
Arm 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(s)
MGB-BP-3
Other Intervention Name(s)
No other names - not applicable
Intervention Description
MGB-BP-3
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events assessed by the Investigator, as per CTCAE v.5.0.
Description
Incidence of treatment emergent adverse events (Safety and Tolerability of up to 3 incremental doses of MGB-BP-3 in patients with CDAD).
Time Frame
40 days
Title
Initial cure rate at 12 days post initiation of therapy.
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.
Time Frame
12 days
Secondary Outcome Measure Information:
Title
CDAD Recurrence
Description
Recurrence of CDAD within 4 weeks (8 weeks optional) post end of treatment.
Time Frame
Up to 8 weeks
Title
Peak plasma concentration (Cmax).
Description
Days 1, 5 and 10.
Time Frame
10 days
Title
Time to peak plasma concentration (Tmax).
Description
Days 1, 5 and 10.
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria: Age 18 years or older of any gender. Inpatients and/or outpatients who are able to attend all scheduled visits. Patients with the first episode or the first recurrence of mild or moderate CDAD. 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: Patients with severe complicated CDAD (including hypotension or shock, ileus, megacolon, pseudomembranous colitis). A white blood cell count higher than 15,000 cells/mL. A serum creatinine level greater than or equal to 1.5 times ULN. Elevated liver enzymes alanine aminotransferase and aspartate aminotransferase greater than ULN. Inflammatory bowel disease (ulcerative colitis or Crohn's disease), microscopic colitis, or irritable bowel syndrome with chronic diarrhea. Any other non-C difficile diarrhea. Received treatment with a fecal transplant within 7 days and/or is anticipated to receive a fecal transplant during the study. Major gastrointestinal surgery (ie, significant bowel resection) within 3 months of enrollment (does not include appendectomy or cholecystectomy). Received laxatives within the previous 48 hours. Pregnant or lactating women. Prior (within 180 days of Screening) or current use of anti-toxin antibodies. Have received a vaccine against C difficile. Any condition for which, in the opinion of the investigator, the treatment may pose a health risk to the patient.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miroslav Ravic, MD
Organizational Affiliation
MGB Biopharma Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Florida International Medical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Omega Research Maitland LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32810
Country
United States
Facility Name
Snake River Research PLLC
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Ochsner Clinic Foundation Infectious Disease Research
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Anne Arundel Medical Centre
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Mercury Street Medical Group PLLC
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Biopharma Informatic LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
Verity Research Inc.
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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