Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00502086
Recruitment Status : Completed
First Posted : July 17, 2007
Last Update Posted : February 11, 2011
Information provided by:
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.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 2005
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

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 Name: Nutritional supplement

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

Primary Outcome Measures :
  1. The mortality secondary to liver failure at 96 weeks. [ Time Frame: 96 weeks ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00502086

Layout table for location information
National Institute of Gastroenterology
Plaza de la Revolución, Havana, Cuba, 10400
Sponsors and Collaborators
Catalysis SL
Layout table for investigator information
Principal Investigator: Eduardo Vilar Gómez, PhD National Institute of Gastroenterology, Havana, Cuba
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Eduardo Vilar Gómez, National Institute of Gastroenterology Identifier: NCT00502086    
Other Study ID Numbers: VIUHCV-07
First Posted: July 17, 2007    Key Record Dates
Last Update Posted: February 11, 2011
Last Verified: February 2010
Keywords provided by Catalysis SL:
Chronic hepatitis C
Cirrhosis of the liver
Health-related quality of live
Hepatocellular carcinoma
Nutritional supplement
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Virus Diseases
Hepatitis, Chronic
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Pathologic Processes