Safety and Efficacy of OP2000 (Deligoparin) in the Treatment of Active Ulcerative Colitis

• Status: Completed
• Trial end date: 2002-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the effectiveness and safety of the experimental compound OP2000 (deligoparin) in patients with active ulcerative colitis. Patients eligible for this study will have received (and will continue to receive) stable doses of aminosalicylates (oral, enema and/or suppository), if tolerated. OP2000 is an ultra low molecular weight heparin with anticoagulant (blood thinning) and anti-inflammatory actions that may be of benefit for the treatment of ulcerative colitis.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incara Pharmaceuticals

Criteria

Inclusion Criteria:

• History of ulcerative colitis at least 3 months with biopsy and colonoscopy confirmation.

• Treatment with aminosalicylates at least 28 days, if tolerated.

• Duration of current flare-up at least 7 days.

• Must be able to self administer once-daily subcutaneous (under the skin) injections of study drug.

Exclusion Criteria:

• Disease limited to the rectum.

• Toxic megacolon.

• The use of anticoagulant drugs.

• A history of any bleeding disorder.

• A history of heparin-induced thrombocytopenia.

• Evidence of liver or kidney impairment.

• Women who are pregnant or breast feeding.