Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS) (CD3-OLS)
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|ClinicalTrials.gov Identifier: NCT03931941|
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : March 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Infection Infection Communicable Diseases||Drug: RBX2660||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3 Open-Label Clinical Study to Evaluate the Safety and Tolerability of Rebiotix RBX2660 (Microbiota Suspension) in Subjects With Recurrent Clostridium Difficile Infection|
|Actual Study Start Date :||July 30, 2019|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
RBX2660 is an enema of a microbiota suspension
RBX2660 is a microbiota suspension administered as an enema
Other Name: Microbiota suspension
- Safety and tolerability of RBX2660 in subjects with recurrent CDI. [ Time Frame: Up to 6 months after last study treatment. ]Number of subjects with investigational product- and/or enema-related treatment-emergent adverse events (TEAEs).
- Efficacy of RBX2660 measured at 8 weeks after treatment. [ Time Frame: 8 weeks after completing the study treatment ]The absence of C. difficile diarrhea without the need for retreatment through 8 weeks after administration of the study treatment.
- Sustained clinical response through 6 months after treatment. [ Time Frame: 6 months after completing the study treatment ]Treatment success of the presenting CDI recurrence and no new CDI episodes for greater than 8 weeks through 6 months after completing a study treatment assessed by subject phone interview up to 6 months after the last study treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931941
|Contact: Paul Plumb||651-705-8778||studyinfo@Rebiotix.com|