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

Phase 3

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Dietary Supplement: Viusid; Other: Placebo

• Registration Number: NCT00778843
• Lead Sponsor: Catalysis SL

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-21
• Study First Submitted QC: 2008-10-22
• Study First Posted: 2008-10-23
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-02
• Last Update Posted: 2012-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Viusid	Viusid	-
Placebo	Placebo	Placebo three oral sachets daily during 24 weeks

Primary Outcome Measures

Name	Time	Method
The improvement of serum parameters related to oxidative stress (SOD, AT, MDA, MDA/HNE, GPx, GR, AOP, MPO, PAOP, GSH) at 24 weeks (end of the treatment).	6 months
The improvement of serum parameters related to immune response (IFN alpha, IFN gamma, IL-1 alpha, IL-2, IL-6, IL-10, IL-12, TNF alpha, Anti TNF alpha, Cathepsin L) at 24 weeks (end of the treatment).	6 months

Secondary Outcome Measures

Name	Time	Method
Improvement of aminotransferase levels (ALAT and ASAT) at 24 weeks (end of the treatment).	6 months
Improvement of clinical symptoms and signs at 24 weeks (end of the treatment).	6 months

Trial Locations

Locations (1)

National Institute of Gastroenterology; 🇨🇺 Vedado, Havana, Cuba