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

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Viusid

Group Type EXPERIMENTAL

Viusid

Intervention Type DIETARY_SUPPLEMENT

Viusid, three oral sachets daily during 24 weeks

Placebo

Placebo three oral sachets daily during 24 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo three oral sachets daily during 24 weeks

Interventions

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Viusid

Viusid, three oral sachets daily during 24 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo three oral sachets daily during 24 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* HCV infection confirmed on a positive test for anti-HCV antibody and HCV RNA detectable in serum by Polymerase Chain Reaction.
* Histological diagnosis of chronic hepatitis.
* Patients who were non-responders to previous treatment with pegylated interferon and ribavirin or who had contraindicated the antiviral treatment.
* Age between 18 and 65 years.
* Ability to provide informed consent.
* Absence of significant alcohol ingestion (weekly ethanol consumption of less than 40 g)

Exclusion Criteria

* Presence of other form of liver diseases (viral or autoimmune hepatitis, drug-induced liver disease, nonalcoholic steatohepatitis, metabolic and hereditary liver disease and α-1 antitrypsin deficiency).
* Pregnancy or lactation.
* Decompensated cirrhosis.
* Absence of clinical and ultrasonographic evidence of liver cancer, with α-fetoprotein levels ≤ 200 ng/ml.
* Refusal to participate in the study.
* Concomitant disease with reduced life expectancy.
* Severe psychiatric conditions.
* Drug dependence.
* Co-infection with hepatitis A or B or HIV.
* Pregnancy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No