Chronic Hepatitis C
Conditions
Keywords
Chronic hepatitis C, Oxidative stress, Antioxidant, Cytokines, Nutritional supplement
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.
Interventions
DIETARY_SUPPLEMENTViusid
Viusid, three oral sachets daily during 24 weeks
OTHERPlacebo
Placebo three oral sachets daily during 24 weeks
Sponsors
Catalysis SL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Cuba
Outcome results
None listed