Clinical trial NCT03824795: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Clostridium Difficile Infection
Keywords: Clostridium difficile
CDAD
MGB-BP-3
Novel anti-infective
Efficacy
Tolerability
Safety
Phase IIa
Lead sponsor: MGB Biopharma Limited
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2019-01-31
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with treatment-related adverse events assessed by the Investigator, as per CTCAE v.5.0.
timeFrame: 40 days
measure: Initial cure rate at 12 days post initiation of therapy.
timeFrame: 12 days
Secondary outcomes:
measure: CDAD Recurrence
timeFrame: Up to 8 weeks
measure: Peak plasma concentration (Cmax).
timeFrame: 10 days
measure: Time to peak plasma concentration (Tmax).
timeFrame: 10 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International Medical Research
state: Florida
city: Orlando
country: United States
facility: Omega Research Maitland LLC
state: Florida
city: Idaho Falls
country: United States
facility: Snake River Research PLLC
state: Idaho
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation Infectious Disease Research
state: Louisiana
city: Annapolis
country: United States
facility: Anne Arundel Medical Centre
state: Maryland
city: Butte
country: United States
facility: Mercury Street Medical Group PLLC
state: Montana
city: Houston
country: United States
facility: Biopharma Informatic LLC
state: Texas
city: Fairfax
country: United States
facility: Verity Research Inc.
state: Virginia
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
Study officials:
affiliation: MGB Biopharma Ltd.
name: Miroslav Ravic, MD
role: STUDY_DIRECTOR
References: