Rebiotix, Inc. PUNCH CD 2 Study – Second Clinical Trial Initiated

Update

24 November 2014

Rebiotix has initiated our second clinical trial (PUNCH CD 2) focusing on the treatment of recurrent C. difficile infection!

REBIOTIX, INC.

The PUNCH CD 2 study is a Phase 2B randomized controlled trial to assess the effectiveness and safety of RBX2660 (microbiota suspension) for the treatment of recurrent               Clostridium difficile (C. diff.)  infection.

About the Study   The PUNCH CD 2 study is the first multicenter prospective, multicenter, randomized, placebo-controlled, double-blind study of a microbiota restoration therapy. It has been designed to provide the highest quality of evidence to-date about this non-antibiotic approach to treating recurrent C. diff. infection.

Approximately 117 patients at over 20 sites in the US and Canada are expected to be enrolled in study.

Patients will be randomized into three different study groups: one group will receive two enemas containing RBX2660; another group will receive two enemas without the active drug; and the third group will receive one enema with RBX2660 and one without.  If a patient’s C. diff. infection reoccurs before 8 weeks after treatment, he or she may be eligible to crossover to receive active treatment with RBX2660.

All patients will be followed for 24 months after treatment.

Further Study Details

For more information on the study you may:

Find Out if You Could be Eligible

A physician participating in the PUNCH CD 2 study will determine if you are eligible to participate in the study. However, you can take a brief survey (less than 1 ½ minutes to complete) to learn if you meet the major study eligibility criteria.

How to Enroll as a Participant

If a study physician thinks you may be a good candidate, you will be given complete information about the study including the responsibilities for participation. You can find out if there is a study site near you by reviewing the clinical study site locations for PUNCH CD 2.


Caution: New Drug – Limited by Federal (or United States) law to investigational use.

 

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.