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Completed

NCT Number: NCT00778843

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

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.

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Institute of Gastroenterology

Vedado, La Habana, 10400, Cuba

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Viusid

Dietary Supplement

Viusid, three oral sachets daily during 24 weeks

Placebo

Other

Placebo three oral sachets daily during 24 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 23, 2008
Registry last updated
May 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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