Safety and Efficacy of AST-120 in the Treatment of Antibiotic-Refractory Pouchitis

• Status: Terminated
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label pilot study in which all patients will receive AST-120 for 4 weeks. Patients will discontinue antibiotics at study entry. They may continue other previously prescribed treatments (e.g., probiotics and/or nutritional agents) at the discretion of the study doctor. The purpose of the study is to assess whether the investigational medication AST-120 will be a safe and effective treatment for the symptoms of pouchitis, a chronic inflammatory condition, in patients whose symptoms have not responded well to antibiotics. An initial group of 10 patients will be enrolled. If there are no serious side effects associated with the study drug and at least 3 of the 10 patients respond, a second group of 10 patients may be enrolled. Patients will have clinic visits at the start of the study and at week 4. Patients will be checked by phone on a weekly basis for symptom response, compliance and development of side effects. Endoscopies will be performed at the start of the study and at week 4 or early termination.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ocera Therapeutics
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular

Criteria

Inclusion Criteria:

• Patients with active pouchitis (defined as having a PDAI score > 7) after IPAA for UC, despite at least 14 days of antibiotic therapy. Active pouchitis must be confirmed by endoscopy and histology within 4 weeks of study entry

• Able to give informed consent

• Able and willing to comply with all study procedures

Exclusion Criteria:

• Patients previously treated with infliximab or any investigational immunosuppressant/ immunomodulator for pouchitis

• Patients undergoing chemotherapy for the treatment of cancer

• Presence of other inflammatory diseases of the pouch: Crohn's disease, Cuffitis, active specific infection of the pouch: (e.g., CMV, C. difficile)

• History of non-inflammatory disease of the pouch: decreased pouch compliance, irritable pouch syndrome, afferent or efferent limb obstruction, stricture of pouch

• Ileal pouch patients with familial adenomatous polyposis

• History of other diarrheal illnesses: lactose intolerance, celiac disease, small bowel bacterial overgrowth

• Primary Sclerosing Cholangitis with or without liver transplant

• Uncontrolled systemic disease

• Needing oral or topical 5-ASA, cholestyramine, steroids or immunomodulators

• 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

• Women who are pregnant, breast feeding, or planning to become pregnant during the study

• Women of child-bearing potential who are not willing to use barrier or depot contraception methods

• Use of NSAIDs or aspirin (>3 times per week) within the past 3 weeks