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

This study has been completed.
Sponsor:
Information provided by:
Catalysis SL
ClinicalTrials.gov Identifier:
NCT00502086
First received: July 13, 2007
Last updated: February 10, 2011
Last verified: February 2010
History of Changes
  Purpose

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 Intervention Phase
Cirrhosis
Chronic Hepatitis C
 Dietary Supplement: Viusid (nutritional supplement)
Other: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Catalysis SL:

Primary Outcome Measures:
  • The mortality secondary to liver failure at 96 weeks. [ Time Frame: 96 weeks ] [ Designated as 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 ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: May 2005
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00502086

Locations
Cuba
National Institute of Gastroenterology
Plaza de la Revolución, Havana, Cuba, 10400
Sponsors and Collaborators
Catalysis SL
Investigators
Principal Investigator: Eduardo Vilar Gómez, PhD National Institute of Gastroenterology, Havana, Cuba
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eduardo Vilar Gómez, National Institute of Gastroenterology
ClinicalTrials.gov Identifier: NCT00502086     History of Changes
Other Study ID Numbers: VIUHCV-07
Study First Received: July 13, 2007
Last Updated: February 10, 2011
Health Authority: Cuba: National Coordinating Center of Clinical Trials (CENCEC)

Keywords provided by Catalysis SL:
Chronic hepatitis C
Cirrhosis of the liver
Mortality
Complications
 Health-related quality of live
Hepatocellular carcinoma
Nutritional supplement

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Liver Cirrhosis
Fibrosis
Virus Diseases
Hepatitis C, Chronic
 Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013