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Completed

NCT Number: NCT00383864

Pegylated Interferon and Ribavirin in Hepatitis C Virus Infection After Liver Transplantation.

The purpose of this study was to evaluate the efficacy (and safety) of antiviral therapy in patients with chronic hepatitis C after liver transplantation. The only approved drugs for treatment of hepatitis C are pegylated interferon and ribavirin.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Fibrosis Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Cirrhosis Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Liver Unit, Hospital Clinic

Barcelona, 08036, Spain

About this study

Hepatitis C recurrence after liver transplantation remains the main cause of graft loss after liver transplantation. Several strategies can be used to prevent or treat hepatitis C in the setting of liver transplantation. There are no controlled studies evaluating the efficacy and safety of antiviral treatment (using pegylated interferon and ribavirin) in liver transplant recipients. The main endpoint of this study was: 1) histological outcomes (effect of antiviral treatment on disease progression, i.e. liver fibrosis). The secondary endpoint were 1) Sustained virological response (persistent HCV-RNA clearance) and 2) Safety of pegylated interferon and ribavirin

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chronic hepatitis C defined by liver biopsy and presence of HCV-RNA
  • More than 6 months from liver transplantation
  • Written inform consent

Exclusion criteria

  • Severe hepatitis C recurrence (F3-F4 fibrosis stage, cholestatic hepatitis)
  • Double liver-kidney transplantation
  • Leucopenia (2000) or thrombocytopenia (40.000)
  • Anemia (Hemoglobin lower than 10 g/dL)
  • Renal failure (creatinine > 2 mg/dL)
  • Autoimmune disease
  • All contraindications for interferon and ribavirin therapy

Treatment and study plan

Pegylated Interferon and Ribavirin

Drug

Primary outcomes

  1. Histological improvement (decrease in at least one fibrosis stage in follow-up liver biop

Secondary outcomes

  1. Sustained virological response (persistent HCV-RNA negativation)

  2. Safety of antiviral therapy

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • Schering-Plough

Registry information

Official study title

Randomized Study on the Efficacy and Safety of Pegylated Interferon and Ribavirin in Hepatitis C Virus Infection After Liver Transplantation

Important dates

Study start
2001
Study completion
2006
First posted
Oct 4, 2006
Registry last updated
Oct 6, 2006

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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