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

Information source: Hospital Universitario Ramon y Cajal
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis C

Intervention: Ribavirin (Drug); Colchicine (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Hospital Universitario Ramon y Cajal

Official(s) and/or principal investigator(s):
Agustín Albillos, MD, Principal Investigator, Affiliation: Hospital Universitario Ramón y Cajal
José Luis Calleja, MD, Study Director, Affiliation: Hospital Universitario Puerta de Hierro Majadahonda
Rafael Bañares, MD, Study Director, Affiliation: Hospital General Universitario Gregorio Marañón

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 (>F2) is rather low. Monotherapy with ribavirin reduces ALT levels and necroinflammatory liver activity in up to a half of non-responders to standard antiviral therapy, but without changes in liver fibrosis or viremia. Such a beneficial effect seems to be mainly due to the immunomodulatory effect of ribavirin. Portal pressure, as measured by HVPG, lowers in patients with chronic hepatitis C and advanced fibrosis with end-of-treatment response to peg-interferon plus ribavirin. Portal pressure reduction in this setting relates to a reduction of the necroinflammatory liver activity, but not with fibrosis amelioration. We hypothesize that monotherapy with ribavirin reduces portal pressure in hepatitis C patients with advanced fibrosis by means of its immunomodulatory and anti-inflammatory effects, and could constitute an alternative to non-responders to standard antiviral treatment. Portal pressure measurement has become a validated surrogate outcome measure in chronic liver disease, since decreasing portal pressure has shown consistent improvement in survival and clinical outcomes, such as complications of portal hypertension. The primary aim of this study is to investigate whether ribavirin monotherapy slows the progression of advanced chronic liver disease by hepatitis C as assessed by a reduction in HVPG.

Clinical Details

Official title: Phase II Trial of Long-term Monotherapy With Ribavirin Against Colchicine on Progression of Chronic Hepatitis C With Advanced Fibrosis in Patients With Non-response to Standard Antiviral Therapy

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

Primary outcome: Hepatic disease progression defined by a difference of >2 mmHg in the hepatic venous gradient between the basal values and the end of treatment values in both groups

Secondary outcome: Decrease in the necroinflammatory activity and in the progression of fibrosis. Normalization of ALT levels.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Criteria:

- 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

Locations and Contacts

Hospital General Universitario Gregorio Marañón, Madrid 28007, Spain

Hospital Universitario Puerta de Hierro-Majadahonda, Madrid 28222, Spain

Hospital Universitario Ramon y Cajal, Madrid 28034, Spain

Additional Information

Starting date: January 2009
Last updated: January 30, 2013

Page last updated: August 23, 2015

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