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

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

Tracking Information

• First Submitted Date: October 21, 2008
• First Posted Date: October 23, 2008
• Last Update Posted Date: May 4, 2012
• Study Start Date: October 2008
• Actual Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 22, 2008)

• 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 ]
• 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 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 22, 2008)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Antioxidant and Immunomodulator Properties of Viusid in Patients With Chronic Hepatitis C
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Chronic Hepatitis C

Intervention

• Dietary Supplement: Viusid
  Viusid, three oral sachets daily during 24 weeks
• Other: Placebo
  Placebo three oral sachets daily during 24 weeks

Study Arms

• Experimental: Viusid
  Intervention: Dietary Supplement: Viusid
• Placebo Comparator: Placebo
  Placebo three oral sachets daily during 24 weeks
  Intervention: Other: Placebo

• Publications *: Vilar Gomez E, Gra Oramas B, Soler E, Llanio Navarro R, Ruenes Domech C. Viusid, a nutritional supplement, in combination with interferon alpha-2b and ribavirin in patients with chronic hepatitis C. Liver Int. 2007 Mar;27(2):247-59.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 22, 2008): 60
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 2009
• Actual Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Cuba

Administrative Information

• NCT Number: NCT00778843
• Other Study ID Numbers: VIU-CHC-08
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Catalysis SL
• Study Sponsor: Catalysis SL
• Collaborators: Not Provided

Investigators

• Principal Investigator: Eduardo Vilar Gomez, Ph.D; National Institute of Gastroenterology

• PRS Account: Catalysis SL
• Verification Date: May 2012