Insufficient enrollment
Prospective, Open-label, Single Arm Pilot Study Evaluating the Effect on Virological Response of the Switch From Tacrolimus to Cyclosporin Associated With a Peginterferon Alfa-2a / Ribavirin Bitherapy, in Non-responder or With Recurrent VHC+ Disease Liver Transplanted Patients.
Sponsor study identifier
Secondary identifiers
OTHER · Rennes University Hospital
interventional
11
1 country
13
Study Start
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2008
Actual (reported)Study Completion
December 2009
Actual (reported)In France, 50% of hepatitis C virus carriers develop chronic clinical hepatitis, which may lead to cirrhosis and liver transplantation. Transplant infection by hepatitis C virus is constant after transplantation and recurrence causes chronic liver disease in 50 to 80% of cases. The aim of this study is to assess the efficacy of cyclosporin on C virological response. Patients included in the Transpeg 1 study and non-responder or with a recurrent disease will be switched from their tacrolimus therapy to cyclosporin, in association with a 1 year peginterferon alfa-2a / ribavirin bitherapy. Efficacy will be assessed by the percentage of patients with a negative qualitative PCR after 19 months of cyclosporin treatment.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2009
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
September 12, 2006
Actual (reported)September 13, 2006
Actual (reported)October 2008
Actual (reported)December 2009
Actual (reported)Prolonged virological response
Percentage of patients with a negative qualitative PCR, 19 months after the initiation of cyclosporin treatment.
19 months
Virological response 4, 7 and 13 months after the initiation of cyclosporin treatment
4, 7 and 13 months
Histological response: METAVIR score at 19 months
19 months
Biological response: liver function at 4, 7, 13 and 19 months
4, 7, 13 and 19 months
Incidence of acute or chronic graft rejection at 19 months
19 months
Incidence of death, graft loss and retransplantation at 13 and 19 months
13 and 19 months
ciclosporin administered orally twice a day, at the initial dosing of 2.5 mg/kg/d, adjusted to obtain a C2 concentration of 600 ng/ml associated with the usual ribavirin and PEGinterferon bitherapy.
Service d'Hépatologie - Hôpital Jean Minjoz
Besançon, 25030, France
Service d'Hépatogastroentérologie - Hôpital Beaujon
Clichy, 92118, France
Service d'Hépatologie et Gastroentérologie - CH Henri Mondor
Créteil, 94010, France
Service des Maladies de l'Appareil Digestif - CHRU Claude Huriez
Lille, 59037, France
Service de Chirurgie Générale - Hôpital Edouard Herriot
Lyon, 69437, France
Chirurgie Générale - Hôpital de la Conception
Marseille, 13385, France
Service d'Hépato-gastro-entérologie - Hôpital Saint Eloi
Yvon Calmus, MD, PhD
Hôpital Cochin, Paris
Eric Bellissant, MD, PhD
Rennes University Hospital
11 participants (actual enrollment reported by the registry).
First Submitted
September 12, 2006
First Posted
September 13, 2006
Study Start
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
Long-term Study of Ciclosporin for Atopic Dermatitis
Contact the study team to confirm eligibility.
Montpellier, 34295, France
Chirurgie Viscérale et Digestive - Hôpital de l'Archet
Nice, 06200, France
Service de Chirurgie Générale - Hôpital Cochin
Paris, 75679, France
Service des Maladies du Foie - Hôpital Pontchaillou
Rennes, 35033, France
Service de Chirurgie Générale et Transplantation Multi-organe - Hôpital de la Hautepierre
Strasbourg, 67098, France
Service d'Hépato-gastro-entérologie - Hôpital de Rangueil
Toulouse, 31403, France
Centre Hépato-Biliaire - Hôpital Paul Brousse
Villejuif, 94804, France
Primary Completion
October 2008
Actual (reported)Study Completion
December 2009
Actual (reported)Last Updated
March 2, 2012
Record last verified: 2012-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: