Status:
COMPLETED
Antioxidant and Immunomodulator Properties of Viusid in Patients With Chronic Hepatitis C
Lead Sponsor:
Catalysis SL
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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. Previou...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00778843
Start Date
October 1 2008
End Date
May 1 2009
Last Update
May 4 2012
Active Locations (1)
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1
National Institute of Gastroenterology
Vedado, La Habana, Cuba, 10400