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

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ClinicalTrials.gov Identifier: NCT00502086
Recruitment Status : Completed
First Posted : July 17, 2007
Last Update Posted : February 11, 2011
Sponsor:
Information provided by:
Catalysis SL

Tracking Information
First Submitted Date  ICMJE July 13, 2007
First Posted Date  ICMJE July 17, 2007
Last Update Posted Date February 11, 2011
Study Start Date  ICMJE May 2005
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2007)
The mortality secondary to liver failure at 96 weeks. [ Time Frame: 96 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2007)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Viusid in Patients With Hepatic Cirrhosis Secondary to Hepatitis C Virus Infection.
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Cirrhosis
  • Chronic Hepatitis C
Intervention  ICMJE
  • Dietary Supplement: Viusid (nutritional supplement)
    Viusid three sachets daily during 96 weeks
    Other Name: Nutritional supplement
  • Other: Placebo
    Placebo three sachets daily during 96 weeks
Study Arms  ICMJE
  • Experimental: I
    Viusid, three sachets daily during 96 weeks
    Intervention: Dietary Supplement: Viusid (nutritional supplement)
  • Placebo Comparator: 2
    Placebo three sachets daily during 96 weeks
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 8, 2009)
100
Original Estimated Enrollment  ICMJE
 (submitted: July 13, 2007)
96
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Cuba
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00502086
Other Study ID Numbers  ICMJE VIUHCV-07
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eduardo Vilar Gómez, National Institute of Gastroenterology
Study Sponsor  ICMJE Catalysis SL
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eduardo Vilar Gómez, PhD National Institute of Gastroenterology, Havana, Cuba
PRS Account Catalysis SL
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP