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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00383864
• Other study ID #: PEG/RBV POST-TOH
• Status: Completed
• Phase: Phase 4
• First received: October 2, 2006
• Last updated: October 5, 2006
• Start date: July 2001
• Est. completion date: March 2006

Study information

• Verified date: October 2006
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Virus Diseases

Intervention

Drug:
• Pegylated interferon and ribavirin

Locations

Country	Name	City	State
Spain	Liver Unit, Hospital Clinic	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Schering-Plough

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histological improvement (decrease in at least one fibrosis stage in follow-up liver biop
Secondary	Sustained virological response (persistent HCV-RNA negativation)
Secondary	Safety of antiviral therapy