A DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF AST-120 IN MILD TO MODERATELY ACTIVE CROHN’S PATIENTS WITH FISTULAS
- Conditions
- The two main categories of inflammatory bowel disease (IBD) are ulcerative colitis and Crohn’s disease. Crohn’s disease is characterized by recurring episodes of suppurative inflammation of any part of the bowel, from the mouth to the anus. This can result in strictures, microperforations, and fistulas. Crohn’s patients typically expetience fever, weight loss, stomatitis, perianal fistulae and/or fissures, arthritis, and erythema nodosum.
- Registration Number
- EUCTR2005-005363-28-GB
- Lead Sponsor
- Ocera Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 240
18 to 70 years of age
Body Weight: (=40 kg)
Documented diagnosis of Crohn’s disease, including patients with documented diagnosis of ileitis, colitis, or ileocolitis
Presence of at least one draining perianal fistula. Patients with enterocutaneous fistulas can be included if they have = 1 draining perianal fistula. Women with rectovaginal fistulas are included if they have = 1 draining perianal fistula.
Crohn’s Disease Activity Index (CDAI) score < 400
Platelet count (thrombocytes) =100,000/µL
Able and willing to comply with all protocol procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients previously treated with infliximab for fistulas cuased by Crohn's disease and who did not respond to infliximab therapy.
Infliximab 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 setons are removed at least 48 hours prior to study entry
Presence of entero-entero, recto-vesicular, entero-vesicular fistulas
The 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)
Receiving Total Parenteral Nutrition (TPN) as the sole source of nutrition within 3 weeks of Screen
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this study is to evaluate the safety and efficacy of AST-120 in the treatment of mild to moderately severe fistulizing Crohn’s disease.;Secondary Objective: ;<br> Primary end point(s): The primary efficacy endpoint is treatment success in the therapy for mild to moderate Crohn’s disease with fistulas defined by: A reduction of at least 50% in the number of draining fistulas at both week 4 and week 8.<br><br> The primary safety endpoint is adverse events (AEs) deemed possibly, probably, or definitely related to treatment with investigational product during 8 weeks of treatment.<br>
- Secondary Outcome Measures
Name Time Method