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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Catalysis SL
ClinicalTrials.gov Identifier:
NCT00778843
First received: October 21, 2008
Last updated: May 2, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Chronic Hepatitis C
Dietary Supplement: Viusid
Other: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Catalysis SL:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement of aminotransferase levels (ALAT and ASAT) at 24 weeks (end of the treatment). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Improvement of clinical symptoms and signs at 24 weeks (end of the treatment). [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: October 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778843

Locations
Cuba
National Institute of Gastroenterology
Vedado, Havana, Cuba, 10400
Sponsors and Collaborators
Catalysis SL
Investigators
Principal Investigator: Eduardo Vilar Gomez, Ph.D National Institute of Gastroenterology
  More Information

Additional Information:
Publications:
Responsible Party: Catalysis SL
ClinicalTrials.gov Identifier: NCT00778843     History of Changes
Other Study ID Numbers: VIU-CHC-08
Study First Received: October 21, 2008
Last Updated: May 2, 2012
Health Authority: Cuba: Ministry of Public Health

Keywords provided by Catalysis SL:
Chronic hepatitis C
Oxidative stress
Antioxidant
Cytokines
Nutritional supplement

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Adjuvants, Immunologic
Antioxidants
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on November 27, 2014