Efficacy and Safety of Viusid in Patients With Hepatic Cirrhosis Secondary to Hepatitis C Virus Infection.

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Viusid, a Nutritional Supplement, in Patients With Hepatic Cirrhosis Secondary to Hepatitis C Virus Infection. A Randomized, Controlled and Double Blind Study.

Conditions
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Cirrhosis, Chronic Hepatitis C

Intervention / Treatment
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* Dietary Supplement: Viusid (nutritional supplement)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br>Viusid, three sachets daily during 96 weeks | Dietary Supplement: Viusid (nutritional supplement)<br>* Viusid three sachets daily during 96 weeks<br>* Other names: Nutritional supplement;|
| Placebo Comparator: 2<br>Placebo three sachets daily during 96 weeks | Other: Placebo<br>* Placebo three sachets daily during 96 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mortality secondary to liver failure at 96 weeks. |  | 96 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic hepatitis C, Cirrhosis of the liver, Mortality, Complications, Health-related quality of live, Hepatocellular carcinoma, Nutritional supplement