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

M

MGB Biopharma

Status and phase

Completed
Phase 2

Conditions

Clostridium Difficile Infection

Treatments

Drug: MGB-BP-3

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03824795
2015-000489-73 (EudraCT Number)
129507 (Other Identifier)
MGB-BP-3-201 (Other Identifier)
1011464

Details and patient eligibility

About

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).

Full 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.

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

34 participants in 3 patient groups

Group 1: 125mg b.i.d. for 10 days
Active Comparator group
Description:
Patients will be administered an oral dose of 125mg b.i.d. MGB-BP-3 for 10 days (Day 1 to Day 10).
Treatment:
Drug: MGB-BP-3
Group 2: 250mg b.i.d. for 10 days
Active Comparator group
Description:
Patients will be administered an oral dose of 250mg b.i.d. MGB-BP-3 for 10 days (Day 1 to Day 10).
Treatment:
Drug: MGB-BP-3
Group 3: 500mg b.i.d. for 10 days
Active Comparator group
Description:
Patients will be administered an oral dose of 500mg b.i.d. MGB-BP-3 for 10 days (Day 1 to Day 10).
Treatment:
Drug: MGB-BP-3

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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