Status:

TERMINATED

Efficacy of Long-term Ribavirin in Non-responders With Chronic Hepatitis C and Advanced Fibrosis

Lead Sponsor:

Hospital Universitario Ramon y Cajal

Conditions:

Chronic Hepatitis C

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

Brief Summary

The rate of sustained virological response to a course of standard antiviral therapy (peg-interferon plus ribavirin) of patients with chronic hepatitis C infected by genotype 1 with advanced fibrosis ...

Eligibility Criteria

Inclusion

  • HCV RNA in serum
  • AST/ALT greater than the upper limit of normal range
  • HVPG \>5 mm Hg
  • Non-response or contraindication to a standard course of antiviral therapy

Exclusion

  • Active alcoholism
  • HIV infection
  • Serum creatinine \>1.2 mg/dl, hemoglobin \<11 g/dl, hemolysis, symptomatic ischemic heart disease or cerebrovascular disease
  • Decompensated chronic liver disease
  • Pregnancy
  • Hypersensitivity to the drugs of the study
  • Severe concomitant disease

Key Trial Info

Start Date :

January 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2012

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT00840489

Start Date

January 1 2009

End Date

December 1 2012

Last Update

January 31 2013

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Hospital General Universitario Gregorio Marañón

Madrid, Madrid, Spain, 28007

2

Hospital Universitario Ramon y Cajal

Madrid, Madrid, Spain, 28034

3

Hospital Universitario Puerta de Hierro-Majadahonda

Madrid, Madrid, Spain, 28222