Status:
COMPLETED
Study to Assess Safety, Tolerability and Efficacy of Incremental Doses of MGB-BP-3 in Patients With CDAD
Lead Sponsor:
MGB Biopharma Limited
Collaborating Sponsors:
Syneos Health
Conditions:
Clostridium Difficile Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 b...
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
Key Trial Info
Start Date :
February 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2020
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03824795
Start Date
February 7 2019
End Date
April 3 2020
Last Update
April 15 2020
Active Locations (9)
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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