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

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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 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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ocera Therapeutics

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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