MICI-CMV:Valganciclovir in Recurrent Bouts of Cryptogenic Inflammatory Bowel Diseases With an Infection by Cytomegalovirus

• Status: Terminated
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of this study is to demonstrate the relevance of Valganciclovir on recurrent bouts of cryptogenic inflammatory bowel diseases with infection by cytomegalovirus (CMV). The goal is to obtain 90% (for Valganciclovir treated patients) versus 50% (for placebo treated patients) remission at 3 months (including the discontinuation of corticoids or reducing their dose to under 20 mg of prednisone equivalence), without any relapse over the 6 following months.

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

Details

• Lead Sponsor: University Hospital, Grenoble
• Treatments: Ganciclovir; Valganciclovir

Criteria

Inclusion Criteria:

• Patient suffering from Crohn's disease, ulcerative colitis, unclassifiable colitis or pouchitis.

• Disease needing to be treated by corticoids and/or immunosuppressive drugs.

• Infection by cytomegalovirus.

• New attack during the three previous months.

Exclusion Criteria:

• Serious or complicated attack, needing to be operated.

• Patient suffering from a psychiatric disease or is uncooperative.

• Patient suffering from another serious disease.

• Patient already participating in another clinical trial.