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

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00383864
First received: October 2, 2006
Last updated: October 5, 2006
Last verified: October 2006
  Purpose

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.


Condition Intervention Phase
Hepatitis C
Drug: Pegylated interferon and ribavirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Study on the Efficacy and Safety of Pegylated Interferon and Ribavirin in Hepatitis C Virus Infection After Liver Transplantation

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Histological improvement (decrease in at least one fibrosis stage in follow-up liver biop

Secondary Outcome Measures:
  • Sustained virological response (persistent HCV-RNA negativation)
  • Safety of antiviral therapy

Estimated Enrollment: 55
Study Start Date: July 2001
Estimated Study Completion Date: March 2006
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00383864

Locations
Spain
Liver Unit, Hospital Clinic
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Schering-Plough
Investigators
Principal Investigator: Xavier Forns, MD Liver Unit, Hospital Clinic, Barcelona
  More Information

No publications provided by Hospital Clinic of Barcelona

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00383864     History of Changes
Other Study ID Numbers: PEG/RBV POST-TOH
Study First Received: October 2, 2006
Last Updated: October 5, 2006
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:
liver fibrosis
portal pressure
antiviral therapy

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014