Overview

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