Treatment of Recurrent Hepatitis C After Liver Transplantation
TRANSPEG
Comparison of Maintenance Treatment by Ribavirin to a Placebo, After an Initial One-year Treatment With Pegylated Interferon-α2a - Ribavirin Association in Hepatitis C Viral Recurrence After Liver Transplantation
3 other identifiers
interventional
200
1 country
16
Brief Summary
In France, 50% of the 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. This recurrence usually causes chronic liver disease, in 50 to 80% of the patients. The interest of a long-term treatment with ribavirin alone after transplantation has not been clearly demonstrated. The objective of our study is to evaluate the efficacy of ribavirin as a maintenance treatment after a one year interferon-α / ribavirin therapy on hepatitis C recurrence in the transplanted liver.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2002
Typical duration for phase_3
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 9, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedMay 21, 2012
November 1, 2007
September 8, 2005
May 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Negative viral PCR
30 months
Secondary Outcomes (8)
Histological improvement
30 months
Biological hepatic markers
30 months
Quality of life
30 months
Intensity, severity and delay to acute transplant rejection, histologically proven
30 months
Incidence of death or graft loss
30 months
- +3 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALRibavirin maintenance treatment
2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- First liver transplantation or retransplantation in the month after initial transplantation
- Patients aged over 18 years
- Post-hepatitis C cirrhosis
- Equilibrated immunosuppressive treatment
- Positive PCR for hepatitis C virus
- Liver biopsy between 6 months and 5 years after the transplantation with a fibrosis Metavir score at least F1
- Hemoglobin ≥ 10 g/dl
- Platelet count ≥ 50.000/mm3
- Normal TSH value
- Serum creatinine \< 200µmol/l
- Informed written consent
You may not qualify if:
- Chronic rejection
- Multi-visceral transplantation
- Renal or cardiac failure, severe sepsis
- Uncontrolled diabetes
- Pregnancy
- Contra-indication to ribavirin or interferon
- History of or current psychiatric troubles
- Thyroid disease uncontrolled by treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rennes University Hospitallead
- Ministry of Health, Francecollaborator
- ANRS, Emerging Infectious Diseasescollaborator
Study Sites (16)
Service d'Hépatologie - Hôpital Jean Minjoz
Besançon, 25030, France
Service de Chirurgie Digestive - Groupe Hospitalier Pellerin-Tripode
Bordeaux, 33000, France
Service d'Hépatogastroentérologie - Hôpital Beaujon
Clichy, 92110, France
Service d'Hépatologie et Gastroentérologie - Hôpital Henri Mondor
Créteil, 94010, France
Service des Maladies de l'Appareil Digestif - CHRU Claude Huriez
Lille, 59037, France
Médecine Digestive - Hôtel Dieu
Lyon, 69288, France
Service de Chirurgie Générale - Hôpital Edouard Herriot
Lyon, 69437, France
Chirurgie Générale - Hôpital de la Conception
Marseille, 13385, France
Service d'Hépaogastroentérologie - Hôpital Saint Eloi
Montpellier, France
Chirurgie Viscérale et Digestive -Hôpital de l'Archet
Nice, 06202, France
Service Hépato-gastroentérologie - Hôpital Saint Antoine
Paris, 75571, France
Service de Chirurgie Générale et Digestive - Hôpital Cochin
Paris, 75679, France
Département de Chirurgie Viscérale- Hôpital Pontchaillou
Rennes, 35033, France
Service de Chirurgie Générale et Transplantation Multi-organe - Hôpital de la Hautepierre
Strasbourg, 67098, France
Hôpital de Rangueil
Toulouse, 31403, France
Centre Hépato-biliaire - Hôpital Paul Brousse
Villejuif, France
Related Publications (2)
Cattral MS, Hemming AW, Wanless IR, Al Ashgar H, Krajden M, Lilly L, Greig PD, Levy GA. Outcome of long-term ribavirin therapy for recurrent hepatitis C after liver transplantation. Transplantation. 1999 May 15;67(9):1277-80. doi: 10.1097/00007890-199905150-00014.
PMID: 10342322BACKGROUNDBerenguer M, Prieto M, Cordoba J, Rayon JM, Carrasco D, Olaso V, San-Juan F, Gobernado M, Mir J, Berenguer J. Early development of chronic active hepatitis in recurrent hepatitis C virus infection after liver transplantation: association with treatment of rejection. J Hepatol. 1998 May;28(5):756-63. doi: 10.1016/s0168-8278(98)80224-9.
PMID: 9625309BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karim Boudjema, MD, PhD
CHU Rennes
- PRINCIPAL INVESTIGATOR
Yvon Calmus, MD
AP-HP Hôpital Cochin
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 9, 2005
Study Start
February 1, 2002
Study Completion
July 1, 2006
Last Updated
May 21, 2012
Record last verified: 2007-11