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

Cirrhosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00502086
• Other study ID #: VIUHCV-07
• Status: Completed
• Phase: Phase 3
• First received: July 13, 2007
• Last updated: February 10, 2011
• Start date: May 2005
• Est. completion date: July 2009

Study information

• Verified date: February 2010
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cuba: National Coordinating Center of Clinical Trials (CENCEC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 a-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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Cirrhosis
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Liver Cirrhosis
• Virus Diseases

Intervention

Dietary Supplement:
• Viusid (nutritional supplement)
Viusid three sachets daily during 96 weeks

Other:
• Placebo
Placebo three sachets daily during 96 weeks

Locations

Country	Name	City	State
Cuba	National Institute of Gastroenterology	Plaza de la Revolución	Havana

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Cuba, 

References & Publications (1)

Vilar Gomez E, Gra Oramas B, Soler E, Llanio Navarro R, Ruenes Domech C. Viusid, a nutritional supplement, in combination with interferon alpha-2b and ribavirin in patients with chronic hepatitis C. Liver Int. 2007 Mar;27(2):247-59. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mortality secondary to liver failure at 96 weeks.		96 weeks	Yes
Secondary	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	Yes