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

Sponsor

Catalysis SL (Industry)

Overall Status

Completed

CT.gov ID

NCT00502086

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis Chronic Hepatitis C	Dietary Supplement: Viusid (nutritional supplement) Other: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official 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.

Study Start Date :

May 1, 2005

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: I Viusid, three sachets daily during 96 weeks	Dietary Supplement: Viusid (nutritional supplement) Viusid three sachets daily during 96 weeks Other Names: Nutritional supplement
Placebo Comparator: 2 Placebo three sachets daily during 96 weeks	Other: Placebo Placebo three sachets daily during 96 weeks

Arm

Intervention/Treatment

Experimental: I

Viusid, three sachets daily during 96 weeks

Dietary Supplement: Viusid (nutritional supplement)

Viusid three sachets daily during 96 weeks

Other Names:

Nutritional supplement

Placebo Comparator: 2

Placebo three sachets daily during 96 weeks

Other: Placebo

Placebo three sachets daily during 96 weeks

Outcome Measures

Primary Outcome Measures

The mortality secondary to liver failure at 96 weeks. [96 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.