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Treatment of Recurrent Hepatitis C After Liver Transplantation (TRANSPEG)

Primary Purpose

Liver Transplantation, Hepatitis C

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Ribavirin
Placebo
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Transplantation focused on measuring Hepatitis C, Viral recurrence, Ribavirin / Interferon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: Chronic rejection Acute rejection at inclusion Multi-visceral transplantation Renal or cardiac failure, severe sepsis Uncontrolled diabetes Positive serology for hepatitis B or HIV at inclusion EBV virus replication at inclusion Hepatocellular carcinoma at inclusion Cirrhosis with a fibrosis Metavir score F4 at inclusion Inclusion in another clinical trial less than one month ago Pregnancy Contra-indication to ribavirin or interferon History of or current psychiatric troubles Thyroid disease uncontrolled by treatment

Sites / Locations

  • Service d'Hépatologie - Hôpital Jean Minjoz
  • Service de Chirurgie Digestive - Groupe Hospitalier Pellerin-Tripode
  • Service d'Hépatogastroentérologie - Hôpital Beaujon
  • Service d'Hépatologie et Gastroentérologie - Hôpital Henri Mondor
  • Service des Maladies de l'Appareil Digestif - CHRU Claude Huriez
  • Médecine Digestive - Hôtel Dieu
  • Service de Chirurgie Générale - Hôpital Edouard Herriot
  • Chirurgie Générale - Hôpital de la Conception
  • Service d'Hépaogastroentérologie - Hôpital Saint Eloi
  • Chirurgie Viscérale et Digestive -Hôpital de l'Archet
  • Service Hépato-gastroentérologie - Hôpital Saint Antoine
  • Service de Chirurgie Générale et Digestive - Hôpital Cochin
  • Département de Chirurgie Viscérale- Hôpital Pontchaillou
  • Service de Chirurgie Générale et Transplantation Multi-organe - Hôpital de la Hautepierre
  • Hôpital de Rangueil
  • Centre Hépato-biliaire - Hôpital Paul Brousse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Ribavirin maintenance treatment

Outcomes

Primary Outcome Measures

Negative viral PCR

Secondary Outcome Measures

Histological improvement
Biological hepatic markers
Quality of life
Intensity, severity and delay to acute transplant rejection, histologically proven
Incidence of death or graft loss
Number of patients stopping the treatment and causes
Incidence of adverse events classically related to treatment
Incidence of adverse events possibly related to treatment

Full Information

First Posted
September 8, 2005
Last Updated
May 18, 2012
Sponsor
Rennes University Hospital
Collaborators
Ministry of Health, France, ANRS, Emerging Infectious Diseases
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1. Study Identification

Unique Protocol Identification Number
NCT00151580
Brief Title
Treatment of Recurrent Hepatitis C After Liver Transplantation
Acronym
TRANSPEG
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rennes University Hospital
Collaborators
Ministry of Health, France, ANRS, Emerging Infectious Diseases

4. Oversight

5. Study Description

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.
Detailed Description
Several therapeutic patterns have been described for the treatment of hepatitis C post-transplantation recurrence. A combination treatment associating interferon-α and ribavirin has shown some efficacy, but this efficacy has not been assessed yet in a placebo-controlled double-blind clinical trial. In our study, all included transplanted patients will be treated during 1 year with interferon-α and ribavirin. At the end of this period, they will be randomized to receive a maintenance treatment with ribavirin or a placebo for 1 additional year. Efficacy will be assessed on virological response after 30 months of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplantation, Hepatitis C
Keywords
Hepatitis C, Viral recurrence, Ribavirin / Interferon

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Ribavirin maintenance treatment
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
18 months of oral ribavirin maintenance treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
18 months oral placebo treatment
Primary Outcome Measure Information:
Title
Negative viral PCR
Time Frame
30 months
Secondary Outcome Measure Information:
Title
Histological improvement
Time Frame
30 months
Title
Biological hepatic markers
Time Frame
30 months
Title
Quality of life
Time Frame
30 months
Title
Intensity, severity and delay to acute transplant rejection, histologically proven
Time Frame
30 months
Title
Incidence of death or graft loss
Time Frame
30 months
Title
Number of patients stopping the treatment and causes
Time Frame
30 months
Title
Incidence of adverse events classically related to treatment
Time Frame
30 months
Title
Incidence of adverse events possibly related to treatment
Time Frame
30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Chronic rejection Acute rejection at inclusion Multi-visceral transplantation Renal or cardiac failure, severe sepsis Uncontrolled diabetes Positive serology for hepatitis B or HIV at inclusion EBV virus replication at inclusion Hepatocellular carcinoma at inclusion Cirrhosis with a fibrosis Metavir score F4 at inclusion Inclusion in another clinical trial less than one month ago Pregnancy Contra-indication to ribavirin or interferon History of or current psychiatric troubles Thyroid disease uncontrolled by treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karim Boudjema, MD, PhD
Organizational Affiliation
CHU Rennes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yvon Calmus, MD
Organizational Affiliation
AP-HP Hôpital Cochin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Hépatologie - Hôpital Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Service de Chirurgie Digestive - Groupe Hospitalier Pellerin-Tripode
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Service d'Hépatogastroentérologie - Hôpital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Service d'Hépatologie et Gastroentérologie - Hôpital Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
Service des Maladies de l'Appareil Digestif - CHRU Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Médecine Digestive - Hôtel Dieu
City
Lyon
ZIP/Postal Code
69288
Country
France
Facility Name
Service de Chirurgie Générale - Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Chirurgie Générale - Hôpital de la Conception
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Service d'Hépaogastroentérologie - Hôpital Saint Eloi
City
Montpellier
Country
France
Facility Name
Chirurgie Viscérale et Digestive -Hôpital de l'Archet
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Service Hépato-gastroentérologie - Hôpital Saint Antoine
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
Service de Chirurgie Générale et Digestive - Hôpital Cochin
City
Paris
ZIP/Postal Code
75679
Country
France
Facility Name
Département de Chirurgie Viscérale- Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Service de Chirurgie Générale et Transplantation Multi-organe - Hôpital de la Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Hôpital de Rangueil
City
Toulouse
ZIP/Postal Code
31403
Country
France
Facility Name
Centre Hépato-biliaire - Hôpital Paul Brousse
City
Villejuif
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
10342322
Citation
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.
Results Reference
background
PubMed Identifier
9625309
Citation
Berenguer 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.
Results Reference
background

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Treatment of Recurrent Hepatitis C After Liver Transplantation

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