Clinical trial NCT00778843: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C
Keywords: Chronic hepatitis C
Oxidative stress
Antioxidant
Cytokines
Nutritional supplement
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2008-10-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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).
timeFrame: 6 months
measure: 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).
timeFrame: 6 months
Secondary outcomes:
measure: Improvement of aminotransferase levels (ALAT and ASAT) at 24 weeks (end of the treatment).
timeFrame: 6 months
measure: Improvement of clinical symptoms and signs at 24 weeks (end of the treatment).
timeFrame: 6 months
Other outcomes:
Locations:
city: Vedado
country: Cuba
facility: National Institute of Gastroenterology
state: Havana
Study officials:
affiliation: National Institute of Gastroenterology
name: Eduardo Vilar Gomez, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1111/j.1478-3231.2006.01411.x.