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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Chronic Hepatitis C

Intervention / Treatment
-----------------
* Dietary Supplement: Viusid
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Viusid<br> | Dietary Supplement: Viusid<br>* Viusid, three oral sachets daily during 24 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo three oral sachets daily during 24 weeks | Other: Placebo<br>* Placebo three oral sachets daily during 24 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic hepatitis C, Oxidative stress, Antioxidant, Cytokines, Nutritional supplement