Microbiota Restoration Therapy for Recurrent Clostridium Difficile Infection (PUNCH CD3-OLS) (CD3-OLS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03931941|
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : April 19, 2022
|Condition or disease||Intervention/treatment||Phase|
|Clostridium Difficile Infection Infection Communicable Diseases||Drug: RBX2660||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 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 :||September 2022|
|Estimated Study Completion Date :||December 2022|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931941
|Contact: Paul Plumb||651-705-8778||US8-StudyInfo@ferring.com|
|Study Chair:||Teena Chopra, M.D., M.P.H.||Wayne State University|