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

Phase 3

Completed

• Conditions: Cirrhosis; Chronic Hepatitis C
• Interventions: Dietary Supplement: Viusid (nutritional supplement); Other: Placebo

• Registration Number: NCT00502086
• Lead Sponsor: Catalysis SL

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2007-07-13
• Study First Submitted QC: 2007-07-13
• Study First Posted: 2007-07-17
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2010-02
• Last Update Submitted: 2011-02-10
• Last Update Posted: 2011-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I	Viusid (nutritional supplement)	Viusid, three sachets daily during 96 weeks
2	Placebo	Placebo three sachets daily during 96 weeks

Primary Outcome Measures

Name	Time	Method
The mortality secondary to liver failure at 96 weeks.	96 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

National Institute of Gastroenterology; 🇨🇺 Plaza de la Revolución, Havana, Cuba