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

Status: Completed
Study State Date: May 2005
Primary Completion Date: Actual July 2009
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Phase: Phase 3

Sponsor(s):
Catalysis SL
 
Information By: Catalysis SL
Trial Identifier: NCT00502086
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.

Description:  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.

Accepts Healthy Volunteers?: No
Enrollment: 100 Actual
Minimum Age: 18 Years
Maximum Age: 70 Years
Gender(s): Both
Additional Criteria:  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.

Conditions:
Hepatitis C, Chronic
Fibrosis
Cirrhosis
Chronic Hepatitis C
Hepatitis C
Liver Cirrhosis
Virus Diseases
Hepatitis A
Hepatitis
Hepatitis, Chronic
Interventions:
Dietary Supplement: Viusid (nutritional supplement)
Other: Placebo
 
Primary Outcome Measures:
The mortality secondary to liver failure at 96 weeks.
Time Frame: 96 weeks
Safety Issue: Yes

 
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.
Time Frame: 96 weeks
Safety Issue: Yes

 
Patient Groups:
Assigned Interventions:

I: Experimental
Viusid, three sachets daily during 96 weeks
Dietary Supplement: Viusid (nutritional supplement)
Viusid three sachets daily during 96 weeks

 
2: Placebo Comparator
Placebo three sachets daily during 96 weeks
Other: Placebo
Placebo three sachets daily during 96 weeks

 


Investigators:
Principal Investigator: Eduardo Vilar Gómez, PhD, National Institute of Gastroenterology, Havana, Cuba

Responsible Party:
National Institute of Gastroenterology (Eduardo Vilar Gómez)

Study Locations:
+ Show All 1 Study Locations


Cuba
National Institute of Gastroenterology 
Plaza de la Revolución, Cuba

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