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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00383864

Enrollment

Registered

2006-10-04

Start date

2001-07-31

Completion date

2006-03-31

Last updated

2006-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

liver fibrosis, portal pressure, antiviral therapy

Brief summary

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

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

Interventions

DRUGPegylated interferon and ribavirin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Histological improvement (decrease in at least one fibrosis stage in follow-up liver biop	—

Secondary

Measure	Time frame
Sustained virological response (persistent HCV-RNA negativation)	—
Safety of antiviral therapy	—

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026