Chronic Hepatitis C, Cirrhosis
Conditions
Keywords
Chronic hepatitis C, Cirrhosis of the liver, Mortality, Complications, Health-related quality of live, Hepatocellular carcinoma, Nutritional supplement
Brief summary
The purpose of the study is to evaluate whether Viusid, a nutritional supplement, reduce the mortality and the complications (ascites, spontaneous bacterial peritonitis, hepatorenal syndrome, hepatic encephalopathy, gastrointestinal bleeding, sepsis and hepatocellular carcinoma) of patients with cirrhosis of the liver secondary to HCV infection in comparison with placebo, during 96 weeks of treatment.
Interventions
DIETARY_SUPPLEMENTViusid (nutritional supplement)
Viusid three sachets daily during 96 weeks
OTHERPlacebo
Placebo three sachets daily during 96 weeks
Sponsors
Catalysis SL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Histological or clinical diagnosis of cirrhosis. * HCV infection confirmed on a positive test for anti-HCV antibody and HCV RNA detectable in serum by Polymerase Chain Reaction. * Patients who were non-responders to previous treatment with pegylated interferon and ribavirin or naïve patients with decompensated cirrhosis (Child-Pugh score ≥ 7) who had contraindicated the antiviral treatment. * Presence of compensated or decompensated (Stage A, B or C according to the Child-Pugh Classification). * Absence of clinical and ultrasonographic evidence of liver cancer, with α-fetoprotein levels ≤ 200 ng/ml.
Exclusion criteria
* Age less than 18 or greater than 70 years. * Presence of uncontrollable clinical or biochemical complications related to severe liver failure (hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding, serum bilirubin level greater than 5 mg/dL, international normalized ratio greater than 2.5). * Active alcoholism. * Serum creatinine greater than 2 mg/dL. * Hepatocellular carcinoma. * Refusal to participate in the study. * Concomitant disease with reduced life expectancy. * Severe psychiatric conditions. * Co-infection with hepatitis A or B or HIV. * Drug dependence. * Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mortality secondary to liver failure at 96 weeks. | 96 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The complication rates during the treatment. The hepatitis-related quality of live during the treatment. Clinical Activity Index during the treatment. The hepatocellular carcinoma incidence during the treatment. | 96 weeks |
Countries
Cuba
Outcome results
None listed