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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 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03824795
Study type Interventional
Source MGB Biopharma Limited
Contact
Status Completed
Phase Phase 2
Start date February 7, 2019
Completion date April 3, 2020
View Details
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