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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy, Safety and Tolerability of Ribavirin Monotherapy Followed by Combined Treatment With Ribavirin and Hydroxychloroquine in Patients Infected With Hepatitis C

NCT01833845

Hepatitis C

TERMINATED PHASE1/PHASE2

Interest of Ribavirin in the Maintenance Treatment of Liver Fibrosis Using Low Dose Pegylated Interferon alpha2b in Patients With Chronic Hepatitis C Non Responders to Previous Antiviral Therapy.

NCT00323804

Hepatitis C, Chronic Liver Fibrosis

COMPLETED PHASE2/PHASE3

High Dose Versus Standard Dose of Ribavirin in Patients With Chronic Hepatitis C, Genotype 3

NCT00830609

Chronic Hepatitis C

COMPLETED PHASE4

Ribavirin Dose Optimization for the Treatment of Hepatitis C

NCT01289496

Chronic Hepatitis C

COMPLETED PHASE2

High Dose Ribavirin in the Treatment of Chronic Hepatitis C

NCT00944684

Chronic Hepatitis C

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Hepatitis C

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ribavirin

Ribavirin 1000-1200 mg qd

Group Type EXPERIMENTAL

Ribavirin

Intervention Type DRUG

Ribavirin 1000-1200 mg qd for 24 weeks

Colchicine

Colchicine 0.5 mg bd

Group Type ACTIVE_COMPARATOR

Colchicine

Intervention Type DRUG

Colchicine 0.5 mg bd for 24 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ribavirin

Ribavirin 1000-1200 mg qd for 24 weeks

Intervention Type DRUG

Colchicine

Colchicine 0.5 mg bd for 24 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Rebetol Colchimax

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No