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

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.

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Key information

Conditions

Cirrhosis Adenocarcinoma Blood-Borne Infections Carcinoma Carcinoma, Hepatocellular Chronic Disease Chronic Hepatitis C Communicable Diseases Digestive System Diseases Digestive System Neoplasms Disease Attributes Fibrosis Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Institute of Gastroenterology

Plaza de la Revolución, La Habana, 10400, Cuba

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Viusid (nutritional supplement)

Dietary Supplement

Viusid three sachets daily during 96 weeks

Other names: Nutritional supplement

Placebo

Other

Placebo three sachets daily during 96 weeks

Primary outcomes

The mortality secondary to liver failure at 96 weeks.

Time frame: 96 weeks

Secondary outcomes

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.

Time frame: 96 weeks

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study title

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.

Important dates

Study start: 2005
Primary completion: 2009
Study completion: 2009
First posted: Jul 17, 2007
Registry last updated: Feb 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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