Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To explore the safety of orally delivered rhIL-11 in patients with mild to moderate left-sided ulcerative colitis.

To explore the effects of orally administered rhIL-11 on pharmacogenomics in blood samples and in colonic biopsy tissue samples.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Oprelvekin

Criteria

Inclusion Criteria:

• Documented, signed informed consent to participate in this study

• Age greater than or equal to 18 years

• Documented diagnosis of ulcerative colitis by standard clinical criteria, including endoscopy (either flexible sigmoidoscopy or colonoscopy, sufficient to define the proximal limit of disease) with biopsy

Exclusion Criteria:

• Crohn's disease

• Ulcerative proctitis

• Ulcerative colitis extending beyond the splenic flexure