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

This study has been terminated.
(difficulty to include patients)
Information provided by:
University Hospital, Grenoble Identifier:
First received: October 11, 2005
Last updated: April 2, 2009
Last verified: April 2009
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.

Condition Intervention Phase
Cytomegalovirus Infections Inflammatory Bowel Diseases Drug: Valganciclovir Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Relevance of Valganciclovir in Recurrent Bouts of Cryptogenic Inflammatory Bowel Diseases With an Infection by Cytomegalovirus

Resource links provided by NLM:

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Improvement of Crohns disease activity index score
  • Diminution or disappearance of gravity criteria
  • Endoscopy: improvement in appearance of lesions, or healing
  • Anatomopathology: improvement of histological criteria, or total regression
  • Anatomopathology: disappearance of viral infection criteria
  • Virology: reversal of CMV IgG serology and PCR results

Estimated Enrollment: 40
Study Start Date: February 2004
Study Completion Date: December 2007
  Show Detailed Description


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00237653

Gastroenterology Department - University Hospital of Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Principal Investigator: Bruno BONAZ, MD Institut National de la Santé Et de la Recherche Médicale, France
  More Information

Publications: Identifier: NCT00237653     History of Changes
Other Study ID Numbers: DCIC 03 21
Study First Received: October 11, 2005
Last Updated: April 2, 2009

Keywords provided by University Hospital, Grenoble:
Cryptogenic inflammatory bowel diseases
Crohn Disease
colitis, ulcerative

Additional relevant MeSH terms:
Communicable Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Cytomegalovirus Infections
Gastrointestinal Diseases
Digestive System Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Antiviral Agents
Anti-Infective Agents processed this record on August 18, 2017