Safety and Efficacy of AST-120 in Mild to Moderate Crohn's Patients With Fistulas

Completed · Phase 3

Conditions studied: Inflammatory Bowel Disease, Intestinal Fistula

In brief

The objective of this study is to evaluate the safety and effectiveness of the experimental drug AST-120 in treating patients with mild to moderately severe Crohn's disease who have fistulas. The study will test whether or not patients receiving AST-120 experience a greater reduction in number of draining fistulas and improvement of their other Crohn's disease symptoms versus patients who receive placebo (material that does not contain any active medication).

Key facts

Study ID: NCT00321412
Run by: Ocera Therapeutics
People needed: 191
Starts: 2006-03-01
Expected to finish: 2008-09-01
Last updated by the study team: 2014-05-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Body Weight > or = 40kg
Documented diagnosis of Crohn's disease, including patients with documented diagnosis of ileitis, colitis, or ileocolitis
Presence of at least one draining fistula. Patients with enterocutaneous fistulas can be included if they have > or = 1 draining perianal fistula. Women with rectovaginal fistulas can be included if they have > or = 1 draining perianal fistula.
Crohn's Disease Activity Index (CDAI) score < 400
Platelet count (thrombocytes) > or = 100,000/uL
Able and willing to comply with all protocol procedures for the duration of the study
Able and willing to understand, sign and date an informed consent document, and authorize access to protected health information
Females must be postmenopausal, surgically incapable of bearing children, or practicing a reliable method of birth control (hormonal contraceptives, intrauterine devices, spermicide and barrier). Partner/spouse sterility may also qualify at the Investigator's discretion. Females of child-bearing potential must have a negative urine pregnancy test at baseline.

You may not qualify if…

Non-response to infliximab or other biological immunosuppressants/ immunomodulators for fistulas associated with Crohn's disease (response is defined as a > or = 50% reduction from baseline in the number of fistulas over at least four weeks); patients who respond once to infliximab and eventually fail can be included
Infliximab (and/or other biological immunosuppressant/immunomodulatory) therapy within 3 months prior to enrollment in the study
Presence of symptomatic strictures or suggestion of significant clinical obstruction
Patients with setons are excluded, unless the setons are removed within 48 hours prior to study entry
Presence of entero-entero, recto-vesicular, entero-vesicular fistulas
Platelet count (thrombocytes) < 100,000/uL
CDAI score of > or = 400
Patient is unable to stay on a stable dose of concomitant Crohn's disease medication(s) for at least 10 weeks in the opinion of the investigator
Currently symptomatic untreated diarrhea due to conditions other than mild to moderately active Crohn's disease (e.g., bacterial or parasitic gastroenteritis, bile salt diarrhea, etc.)
Severe diarrhea defined by > 10 liquid bowel movements per day
Other local manifestations of mild to moderately active Crohn's disease such as abscesses, or other disease manifestations for which surgery might be indicated or which might preclude utilization of a CDAI to assess response to therapy (e.g., short bowel syndrome)
Presence of an ileostomy
Receiving Total Parenteral Nutrition (TPN) as the sole source of nutrition within 3 weeks of Screen
Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling.
Hemoglobin < 8.5 g/dL (females) or hemoglobin < 10 g/dL (males) at Screen
Women who are pregnant, breast feeding, or planning to become pregnant during the study
Other major physical or major psychiatric illness within the last 6 months that in the opinion of the investigator would affect the patient's ability to complete the trial
Uncontrolled systemic disease
Patients undergoing chemotherapy for the treatment of cancer
Known hypersensitivity or contraindication to any component of the test product (study drugs) or diagnostics used
Participation in another study within eight (8) weeks prior to the study
Unable to attend all visits required by the protocol

Where it is running

Digestive Care Medical Center — San Carlos, California, United States
Shafran Gasteroenterology Center — Winter Park, Florida, United States
Rush University Medical Center — Chicago, Illinois, United States
University of Chicago Medical Center — Chicago, Illinois, United States
Indiana University, Outpatient Clinical Research Facility — Indianapolis, Indiana, United States
University of Kentucky Chandler Medical Center — Lexington, Kentucky, United States
University of Louisville, Department of Surgery — Louisville, Kentucky, United States
Metropolitan Gastroenterology Group/Chevy Chase Clinical Research — Chevy Chase, Maryland, United States
Brigham & Women's Hospital — Boston, Massachusetts, United States
Clinical Research Institute of Michigan, LLC — Chesterfield, Michigan, United States
Drs. Scherf, Chessler, Zingler & Spinnell, MD, PA — Fort Lee, New Jersey, United States
Long Island Clinical Research Associates, LLP — Great Neck, New York, United States
Mount Sinai School of Medicine, IBD Research Center — New York, New York, United States
University of Rochester Medical Center — Rochester, New York, United States
University of North Carolina — Chapel Hill, North Carolina, United States
Carolina Digestive Health Associates — Charlotte, North Carolina, United States
University Hospitals of Cleveland — Cleveland, Ohio, United States
Cleveland Clinic - Department of Gastroenterology — Cleveland, Ohio, United States
The Penn State University, Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
Digestive Disease Center/MUSC — Charleston, South Carolina, United States
Memphis Gastroenterology Group, PC — Germantown, Tennessee, United States
University of Washington — Seattle, Washington, United States
Dean Foundation Research Center — Madison, Wisconsin, United States
Advanced Clinical Research Institute — Anaheim, California, United States

Full record on ClinicalTrials.gov

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