Antioxidant and Immunomodulator Properties of Viusid in Patients With Chronic Hepatitis C

NCT00778843 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2012-05-04

No results posted yet for this study

Summary

The pathogenesis of chronic hepatitis C (CHC) is associated to severe oxidative stress and non-selective immunological disturbance that leads to necro-inflammation and progression of fibrosis. Previous trials suggested that antioxidant and inmunostimulant therapies may have a beneficial effect. The purpose of the study is to evaluate whether Viusid, a nutritional supplement with hepatoprotective properties, could ameliorate the oxidative stress and modulate the immune response in patients with CHC and non-responders to pegylated interferon plus ribavirin, during 24 weeks of treatment.

Conditions

  • Chronic Hepatitis C

Interventions

DIETARY_SUPPLEMENT

Viusid

Viusid, three oral sachets daily during 24 weeks

OTHER

Placebo

Placebo three oral sachets daily during 24 weeks

Sponsors & Collaborators

  • Catalysis SL

    lead INDUSTRY

Principal Investigators

  • Eduardo Vilar Gomez, Ph.D · National Institute of Gastroenterology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • Cuba

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00778843 on ClinicalTrials.gov