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

NCT00237653 | Terminated Phase 3

• 1 other identifier: DCIC 03 21
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cytomegalovirus Infections; Inflammatory Bowel Diseases

Keywords

Valganciclovir; Cytomegalovirus; Cryptogenic inflammatory bowel diseases; Crohn Disease; colitis, ulcerative

Outcome Measures

Primary Outcomes (6)

• 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

Interventions

Valganciclovir DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Gastroenterology Department - University Hospital of Grenoble

Grenoble, 38043, France

Location

Related Publications (13)

• 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. doi: 10.1007/BF01299914. No abstract available.

  PMID: 8261839 BACKGROUND

• 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.

  PMID: 8544671 BACKGROUND

• 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. doi: 10.1136/pgmj.74.874.486.

  PMID: 9926125 BACKGROUND

• 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.

  PMID: 9273986 BACKGROUND

• 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. doi: 10.1111/j.1572-0241.1999.01013.x.

  PMID: 10201482 BACKGROUND

• 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. doi: 10.1007/BF02235178.

  PMID: 10211516 BACKGROUND

• 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.

  PMID: 2859801 BACKGROUND

• Pfau PR, Lichtenstein GR. Cytomegalovirus infection as a cause of ileoanal pouchitis. Dis Colon Rectum. 2000 Jan;43(1):113-4. doi: 10.1007/BF02237255. No abstract available.

  PMID: 10813135 BACKGROUND

• 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. doi: 10.1111/j.1572-0241.2001.03672.x.

  PMID: 11280572 BACKGROUND

• 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. doi: 10.1007/BF02235196.

  PMID: 10211531 BACKGROUND

• Moonka D, Furth EE, MacDermott RP, Lichtenstein GR. Pouchitis associated with primary cytomegalovirus infection. Am J Gastroenterol. 1998 Feb;93(2):264-6. doi: 10.1111/j.1572-0241.1998.00264.x.

  PMID: 9468256 BACKGROUND

• 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. doi: 10.1111/j.1572-0241.2001.03949.x.

  PMID: 11467645 BACKGROUND

• Surawicz CM, Myerson D. Self-limited cytomegalovirus colitis in immunocompetent individuals. Gastroenterology. 1988 Jan;94(1):194-9. doi: 10.1016/0016-5085(88)90630-0.

  PMID: 2826283 BACKGROUND

MeSH Terms

Conditions

Cytomegalovirus Infections; Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

Valganciclovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Ganciclovir; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bruno BONAZ, MD

  Institut National de la Santé Et de la Recherche Médicale, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 11, 2005
• First Posted: October 12, 2005
• Study Start: February 1, 2004
• Study Completion: December 1, 2007
• Last Updated: April 3, 2009

Record last verified: 2009-04

Locations

FR (1)