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Completed

NCT Number: NCT00151580

Treatment of Recurrent Hepatitis C After Liver Transplantation

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.

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Key information

Conditions

Liver Transplantation Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Service d'Hépatologie - Hôpital Jean Minjoz, Besançon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ribavirin

Drug

18 months of oral ribavirin maintenance treatment

Placebo

Drug

18 months oral placebo treatment

Primary outcomes

  1. Negative viral PCR

    Time frame: 30 months

Secondary outcomes

  1. Histological improvement

    Time frame: 30 months

  2. Biological hepatic markers

    Time frame: 30 months

  3. Quality of life

    Time frame: 30 months

  4. Intensity, severity and delay to acute transplant rejection, histologically proven

    Time frame: 30 months

  5. Incidence of death or graft loss

    Time frame: 30 months

  6. Number of patients stopping the treatment and causes

    Time frame: 30 months

  7. Incidence of adverse events classically related to treatment

    Time frame: 30 months

  8. Incidence of adverse events possibly related to treatment

    Time frame: 30 months

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Collaborators

  • ANRS, Emerging Infectious Diseases
  • Ministry of Health, France

Registry information

Official study 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

Acronym: TRANSPEG

Important dates

Study start
2002
Study completion
2006
First posted
Sep 9, 2005
Registry last updated
May 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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