Status:
COMPLETED
Safety and Efficacy of AST-120 in Mild to Moderate Crohn's Patients With Fistulas
Lead Sponsor:
Ocera Therapeutics
Conditions:
Inflammatory Bowel Disease
Intestinal Fistula
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
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 stud...
Detailed Description
The experimental drug AST-120 is composed of black, odorless spherical carbon particles in 2g sachets (aluminum foil pouches). The placebo consists of microcrystalline cellulose spheres, Celphere CP-3...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
191 Patients enrolled
Trial Details
Trial ID
NCT00321412
Start Date
March 1 2006
End Date
September 1 2008
Last Update
May 30 2014
Active Locations (88)
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1
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
2
Digestive Care Medical Center
San Carlos, California, United States, 94070
3
Shafran Gasteroenterology Center
Winter Park, Florida, United States, 32789
4
Rush University Medical Center
Chicago, Illinois, United States, 60612