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

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Pegylated interferon and ribavirin
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring liver fibrosis, portal pressure, antiviral therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Liver Unit, Hospital Clinic

Outcomes

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

Full Information

First Posted
October 2, 2006
Last Updated
October 5, 2006
Sponsor
Hospital Clinic of Barcelona
Collaborators
Schering-Plough
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1. Study Identification

Unique Protocol Identification Number
NCT00383864
Brief Title
Pegylated Interferon and Ribavirin in Hepatitis C Virus Infection After Liver Transplantation.
Official Title
Randomized Study on the Efficacy and Safety of Pegylated Interferon and Ribavirin in Hepatitis C Virus Infection After Liver Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
Schering-Plough

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
liver fibrosis, portal pressure, antiviral therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pegylated interferon and ribavirin
Primary Outcome Measure Information:
Title
Histological improvement (decrease in at least one fibrosis stage in follow-up liver biop
Secondary Outcome Measure Information:
Title
Sustained virological response (persistent HCV-RNA negativation)
Title
Safety of antiviral therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Forns, MD
Organizational Affiliation
Liver Unit, Hospital Clinic, Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liver Unit, Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
17484872
Citation
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.
Results Reference
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Pegylated Interferon and Ribavirin in Hepatitis C Virus Infection After Liver Transplantation.

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