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

Clostridium Difficile Infection Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03824795
• Other study ID #: 1011464
• Secondary ID: 2015-000489-7312
• Status: Completed
• Phase: Phase 2
• Start date: February 7, 2019
• Est. completion date: April 3, 2020

Study information

• Verified date: April 2020
• Source: MGB Biopharma Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 3, 2020
• Est. primary completion date: April 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Clostridium Difficile Infection
• Clostridium Infections

Intervention

Drug:
• MGB-BP-3
MGB-BP-3

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
United States	Anne Arundel Medical Centre	Annapolis	Maryland
United States	Mercury Street Medical Group PLLC	Butte	Montana
United States	Verity Research Inc.	Fairfax	Virginia
United States	Biopharma Informatic LLC	Houston	Texas
United States	Snake River Research PLLC	Idaho Falls	Idaho
United States	Florida International Medical Research	Miami	Florida
United States	Ochsner Clinic Foundation Infectious Disease Research	New Orleans	Louisiana
United States	Omega Research Maitland LLC	Orlando	Florida

Sponsors (2)

Lead Sponsor	Collaborator
MGB Biopharma Limited	Syneos Health

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	40 days
Primary	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.	12 days
Secondary	CDAD Recurrence	Recurrence of CDAD within 4 weeks (8 weeks optional) post end of treatment.	Up to 8 weeks
Secondary	Peak plasma concentration (Cmax).	Days 1, 5 and 10.	10 days
Secondary	Time to peak plasma concentration (Tmax).	Days 1, 5 and 10.	10 days