Working… Menu

Antioxidant and Immunomodulator Properties of Viusid in Patients With Chronic Hepatitis C

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: NCT00778843
Recruitment Status : Completed
First Posted : October 23, 2008
Last Update Posted : May 4, 2012
Information provided by (Responsible Party):
Catalysis SL

Brief Summary:
The pathogenesis of chronic hepatitis C (CHC) is associated to severe oxidative stress and non-selective immunological disturbance that leads to necro-inflammation and progression of fibrosis. Previous trials suggested that antioxidant and inmunostimulant therapies may have a beneficial effect. The purpose of the study is to evaluate whether Viusid, a nutritional supplement with hepatoprotective properties, could ameliorate the oxidative stress and modulate the immune response in patients with CHC and non-responders to pegylated interferon plus ribavirin, during 24 weeks of treatment.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Dietary Supplement: Viusid Other: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Viusid as Antioxidant and Immunomodulator Nutritional Supplement in Patients With Chronic Hepatitis C and Non-responders to Standard Antiviral Therapy. A Randomized and Double Blind Controlled Trial
Study Start Date : October 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Viusid Dietary Supplement: Viusid
Viusid, three oral sachets daily during 24 weeks

Placebo Comparator: Placebo
Placebo three oral sachets daily during 24 weeks
Other: Placebo
Placebo three oral sachets daily during 24 weeks

Primary Outcome Measures :
  1. The improvement of serum parameters related to oxidative stress (SOD, AT, MDA, MDA/HNE, GPx, GR, AOP, MPO, PAOP, GSH) at 24 weeks (end of the treatment). [ Time Frame: 6 months ]
  2. The improvement of serum parameters related to immune response (IFN alpha, IFN gamma, IL-1 alpha, IL-2, IL-6, IL-10, IL-12, TNF alpha, Anti TNF alpha, Cathepsin L) at 24 weeks (end of the treatment). [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Improvement of aminotransferase levels (ALAT and ASAT) at 24 weeks (end of the treatment). [ Time Frame: 6 months ]
  2. Improvement of clinical symptoms and signs at 24 weeks (end of the treatment). [ Time Frame: 6 months ]

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 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • HCV infection confirmed on a positive test for anti-HCV antibody and HCV RNA detectable in serum by Polymerase Chain Reaction.
  • Histological diagnosis of chronic hepatitis.
  • Patients who were non-responders to previous treatment with pegylated interferon and ribavirin or who had contraindicated the antiviral treatment.
  • Age between 18 and 65 years.
  • Ability to provide informed consent.
  • Absence of significant alcohol ingestion (weekly ethanol consumption of less than 40 g)

Exclusion Criteria:

  • Presence of other form of liver diseases (viral or autoimmune hepatitis, drug-induced liver disease, nonalcoholic steatohepatitis, metabolic and hereditary liver disease and α-1 antitrypsin deficiency).
  • Pregnancy or lactation.
  • Decompensated cirrhosis.
  • Absence of clinical and ultrasonographic evidence of liver cancer, with α-fetoprotein levels ≤ 200 ng/ml.
  • Refusal to participate in the study.
  • Concomitant disease with reduced life expectancy.
  • Severe psychiatric conditions.
  • Drug dependence.
  • Co-infection with hepatitis A or B or HIV.
  • 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): NCT00778843

Layout table for location information
National Institute of Gastroenterology
Vedado, Havana, Cuba, 10400
Sponsors and Collaborators
Catalysis SL
Layout table for investigator information
Principal Investigator: Eduardo Vilar Gomez, Ph.D National Institute of Gastroenterology
Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: Catalysis SL Identifier: NCT00778843    
Other Study ID Numbers: VIU-CHC-08
First Posted: October 23, 2008    Key Record Dates
Last Update Posted: May 4, 2012
Last Verified: May 2012
Keywords provided by Catalysis SL:
Chronic hepatitis C
Oxidative stress
Nutritional supplement
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections