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

Chronic Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00778843
• Other study ID #: VIU-CHC-08
• Status: Completed
• Phase: Phase 3
• First received: October 21, 2008
• Last updated: May 2, 2012
• Start date: October 2008
• Est. completion date: May 2009

Study information

• Verified date: May 2012
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cuba: Ministry of Public Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 a-1 antitrypsin deficiency).

• Pregnancy or lactation.

• Decompensated cirrhosis.

• Absence of clinical and ultrasonographic evidence of liver cancer, with a-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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

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

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

Locations

Country	Name	City	State
Cuba	National Institute of Gastroenterology	Vedado	Havana

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Cuba, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).		6 months	No
Primary	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).		6 months	No
Secondary	Improvement of aminotransferase levels (ALAT and ASAT) at 24 weeks (end of the treatment).		6 months	No
Secondary	Improvement of clinical symptoms and signs at 24 weeks (end of the treatment).		6 months	No

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