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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-07-31

Study Completion Date

2006-03-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Hepatitis C

Keywords

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liver fibrosis portal pressure antiviral therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pegylated interferon and ribavirin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Xavier Forns, MD

Role: PRINCIPAL_INVESTIGATOR

Liver Unit, Hospital Clinic, Barcelona

Locations

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Liver Unit, Hospital Clinic

Barcelona, , Spain

Site Status

Countries

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Spain

References

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Carrion JA, Navasa M, Garcia-Retortillo M, Garcia-Pagan JC, Crespo G, Bruguera M, Bosch J, Forns X. Efficacy of antiviral therapy on hepatitis C recurrence after liver transplantation: a randomized controlled study. Gastroenterology. 2007 May;132(5):1746-56. doi: 10.1053/j.gastro.2007.03.041. Epub 2007 Mar 24.

Reference Type DERIVED

PMID: 17484872 (View on PubMed)

Other Identifiers

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PEG/RBV POST-TOH

Identifier Type: -

Identifier Source: org_study_id