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

Sponsored by:	University Hospital, Grenoble
Information provided by:	University Hospital, Grenoble
ClinicalTrials.gov Identifier:	NCT00237653

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 III

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease Cytomegalovirus Infections

Drug Information available for: Valganciclovir Valganciclovir hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Relevance of Valganciclovir in Recurrent Bouts of Cryptogenic Inflammatory Bowel Diseases With an Infection by Cytomegalovirus

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
Estimated Study Completion Date:	December 2006

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

Contacts

Contact: Jean-Luc BOSSON, MD

JLBosson@chu-grenoble.fr

Locations

France
Gastroenterology Department - University Hospital of Grenoble	Recruiting
Grenoble, France, 38043
Contact: Bruno BONAZ, MD BBonaz@chu-grenoble.fr
Sub-Investigator: Joanna Pofelski, Dr

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:

Orvar K, Murray J, Carmen G, Conklin J. Cytomegalovirus infection associated with onset of inflammatory bowel disease. Dig Dis Sci. 1993 Dec;38(12):2307-10. No abstract available.

Hofkin GA, Ting CD. Case report: recurrence of chronic ulcerative colitis induced by intercurrent cytomegalic virus infection. Md Med J. 1995 Dec;44(12):1047-8.

Rachima C, Maoz E, Apter S, Thaler M, Grossman E, Rosenthal T. Cytomegalovirus infection associated with ulcerative colitis in immunocompetent individuals. Postgrad Med J. 1998 Aug;74(874):486-9.

Begos DG, Rappaport R, Jain D. Cytomegalovirus infection masquerading as an ulcerative colitis flare-up: case report and review of the literature. Yale J Biol Med. 1996 Jul-Aug;69(4):323-8. Review.

Vega R, Bertran X, Menacho M, Domenech E, Moreno de Vega V, Hombrados M, Cabre E, Ojanguren I, Gassull MA. Cytomegalovirus infection in patients with inflammatory bowel disease. Am J Gastroenterol. 1999 Apr;94(4):1053-6.

Kaufman HS, Kahn AC, Iacobuzio-Donahue C, Talamini MA, Lillemoe KD, Hamilton SR. Cytomegaloviral enterocolitis: clinical associations and outcome. Dis Colon Rectum. 1999 Jan;42(1):24-30.

Berk T, Gordon SJ, Choi HY, Cooper HS. Cytomegalovirus infection of the colon: a possible role in exacerbations of inflammatory bowel disease. Am J Gastroenterol. 1985 May;80(5):355-60.

Pfau PR, Lichtenstein GR. Cytomegalovirus infection as a cause of ileoanal pouchitis. Dis Colon Rectum. 2000 Jan;43(1):113-4. No abstract available.

Pfau P, Kochman ML, Furth EE, Lichtenstein GR. Cytomegalovirus colitis complicating ulcerative colitis in the steroid-naive patient. Am J Gastroenterol. 2001 Mar;96(3):895-9.

Munoz-Juarez M, Pemberton JH, Sandborn WJ, Tremaine WJ, Dozois RR. Misdiagnosis of specific cytomegalovirus infection of the ileoanal pouch as refractory idiopathic chronic pouchitis: report of two cases. Dis Colon Rectum. 1999 Jan;42(1):117-20.

Moonka D, Furth EE, MacDermott RP, Lichtenstein GR. Pouchitis associated with primary cytomegalovirus infection. Am J Gastroenterol. 1998 Feb;93(2):264-6.

Papadakis KA, Tung JK, Binder SW, Kam LY, Abreu MT, Targan SR, Vasiliauskas EA. Outcome of cytomegalovirus infections in patients with inflammatory bowel disease. Am J Gastroenterol. 2001 Jul;96(7):2137-42.

Surawicz CM, Myerson D. Self-limited cytomegalovirus colitis in immunocompetent individuals. Gastroenterology. 1988 Jan;94(1):194-9.

Study ID Numbers:	DCIC 03 21
Study First Received:	October 11, 2005
Last Updated:	August 28, 2006
ClinicalTrials.gov Identifier:	NCT00237653
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Grenoble:

Valganciclovir
Cytomegalovirus
Cryptogenic inflammatory bowel diseases

Crohn Disease
Crohn disease
colitis, ulcerative

Study placed in the following topic categories:

Valganciclovir
Gastrointestinal Diseases
Ulcer
Inflammatory Bowel Diseases
Ganciclovir
Colitis, Ulcerative
Intestinal Diseases
Cytomegalovirus
Recurrence

Herpesviridae Infections
Virus Diseases
Digestive System Diseases
Crohn Disease
Cytomegalovirus Infections
DNA Virus Infections
Gastroenteritis
Cytomegalic inclusion disease
Colitis

Additional relevant MeSH terms:

Anti-Infective Agents
Communicable Diseases
Therapeutic Uses

Infection
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009