Erythrocytes-Mediated Delivery Of Dexamethasone 21-Phosphate In Steroid-Dependent Ulcerative Colitis

• Status: Unknown status
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the efficacy and safety of erythrocyte-mediated delivery of dexamethasone in steroid-dependent ulcerative colitis patients

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

Details

• Lead Sponsor: Casa Sollievo della Sofferenza IRCCS
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

• adult patients

• steroid-dependent ulcerative colitis

• clinical remission or mild clinical activity

Exclusion Criteria:

• uncontrolled diabetes

• severe comorbidities (renal failure, heart failure, cirrhosis, neoplasia)

• previous exposure to biologic therapy

• pregnancy of breast feeding

• alcohol or drug abuse

• mental illness