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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00237653
Recruitment Status : Terminated (difficulty to include patients)
First Posted : October 12, 2005
Last Update Posted : April 3, 2009
Information provided by:
University Hospital, Grenoble

Brief 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.

Condition or disease Intervention/treatment Phase
Cytomegalovirus Infections Inflammatory Bowel Diseases Drug: Valganciclovir Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Study Start Date : February 2004
Actual Study Completion Date : December 2007

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00237653

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


Layout table for additonal information Identifier: NCT00237653     History of Changes
Other Study ID Numbers: DCIC 03 21
First Posted: October 12, 2005    Key Record Dates
Last Update Posted: April 3, 2009
Last Verified: April 2009

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

Additional relevant MeSH terms:
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Communicable Diseases
Cytomegalovirus Infections
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Antiviral Agents
Anti-Infective Agents