NCT00778843

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

Efficacy and Safety of Viusid as Antioxidant and Immunomodulator Nutritional Supplement in Patients With Chronic Hepatitis C and Non-responders to Standard Antiviral Therapy. A Randomized and Double Blind Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Catalysis SL · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DIETARY_SUPPLEMENT	Viusid	Viusid, three oral sachets daily during 24 weeks
OTHER	Placebo	Placebo three oral sachets daily during 24 weeks

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2008-10-23
• Last updated: 2012-05-04

Locations

1 site across 1 country: Cuba