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

Catalysis SL

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis C

Treatments: Dietary Supplement: Viusid; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00778843

VIU-CHC-08

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Viusid

Experimental group

Treatment:

Dietary Supplement: Viusid

Placebo

Placebo Comparator group

Description:

Placebo three oral sachets daily during 24 weeks

Treatment:

Other: Placebo