Antioxidant and Immunomodulator Properties of Viusid in Patients With Chronic Hepatitis C - Full Text View

Sponsored by:	Catalysis SL
Information provided by:	Catalysis SL
ClinicalTrials.gov Identifier:	NCT00778843

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 III

MedlinePlus related topics: Antioxidants Dietary Supplements Hepatitis Hepatitis C

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

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: Yes ]
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: Yes ]

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: Yes ]
Improvement of clinical symptoms and signs at 24 weeks (end of the treatment). [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	September 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Viusid: Experimental	Dietary Supplement: Viusid Viusid, three oral sachets daily during 24 weeks
Placebo: Placebo Comparator 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 phychiatric conditions.
Drug dependence.
Co-infection with hepatitis A or B or HIV.
Pregnancy.

Contacts and Locations

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

Contacts

Contact: Adelaida Rodríguez de Miranda, MD	5 37 8325594 ext 128	laly@infomed.sld.cu
Contact: Luis Calzadilla Bertot, M.D	8325594 ext 123	luis.calzadilla@infomed.sld.cu

Locations

Cuba, Havana
National Institute of Gastroenterology	Recruiting
Vedado, Havana, Cuba, 10400
Principal Investigator: Eduardo Vilar Gomez, Ph.D

Sponsors and Collaborators

Catalysis SL

Investigators

Principal Investigator:

Eduardo Vilar Gomez, Ph.D

National Institute of Gastroenterology

More Information

Related Info This link exits the ClinicalTrials.gov site

Publications of Results:

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.

Responsible Party:	National Institute of Gastroenterology from Havana ( Catalysis. SL )
Study ID Numbers:	VIU-CHC-08
Study First Received:	October 21, 2008
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00778843
Health Authority:	Cuba: National Coordinating Center of Clinical Trials (CENCEC)

Keywords provided by Catalysis SL:

Chronic hepatitis C
Oxidative stress
Antioxidant
Cytokines
Nutritional supplement

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic

Hepatitis, Viral, Human
Stress
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:

RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on January 14, 2009