Clinical Trials Directory

Trials / Completed

CompletedNCT03497806

Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection

PRISM-EXT: An Open-Label Extension of CP101 Trials Evaluating Oral Full-Spectrum Microbiota™ (CP101) in Subjects With Recurrence of Clostridium Difficile Infection

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
132 (actual)
Sponsor
Finch Research and Development LLC. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is an open-label study evaluating the safety and efficacy of CP101 treatment in 1) Subjects in CDI-001 who had a CDI recurrence within 8 weeks of receiving CP101 or placebo; OR 2) adults with recurrent CDI who are eligible for direct study entry into CP101-CDI-E02. Subjects who are experiencing recurrent CDI will undergo screening procedures. Subjects who meet eligibility criteria will be eligible to be enrolled in he study and administered CP101. Approximately 200 subjects will receive CP101. The treatment duration will be 1 day. Subjects will be monitored for recurrence of CDI, safety, and tolerability for 24 weeks following receipt of CP101. The primary efficacy and safety endpoints will be evaluated at 8 weeks post treatment, and all subjects will continue to be followed for an additional 16 weeks for safety and recurrence of CDI.

Conditions

Interventions

TypeNameDescription
BIOLOGICALCP101Study drug will be administered at Treatment (Day 1) as an oral dose after cessation of standard-of-care CDI antibiotic treatment of the current episode of recurrent CDI.

Timeline

Start date
2018-05-01
Primary completion
2020-12-31
Completion
2021-04-01
First posted
2018-04-13
Last updated
2022-08-30
Results posted
2022-08-30

Locations

57 sites across 2 countries: United States, Canada

Regulatory

Source: ClinicalTrials.gov record NCT03497806. Inclusion in this directory is not an endorsement.