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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)
Sponsor:
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00237653
First received: October 11, 2005
Last updated: April 2, 2009
Last verified: April 2009
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00237653

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

Publications:

ClinicalTrials.gov Identifier: NCT00237653     History of Changes
Other Study ID Numbers: DCIC 03 21
Study First Received: October 11, 2005
Last Updated: April 2, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Cytomegalovirus Infections
Inflammatory Bowel Diseases
Intestinal Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Valganciclovir
Ganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013