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

Primary Purpose

Chronic Hepatitis C

Status

Completed

Phase

Phase 3

Locations

Cuba

Study Type

Interventional

Intervention

Viusid

Placebo

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Chronic hepatitis C, Oxidative stress, Antioxidant, Cytokines, Nutritional supplement

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

National Institute of Gastroenterology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Viusid

Placebo

Arm Description

Placebo three oral sachets daily during 24 weeks

Outcomes

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).

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).

Secondary Outcome Measures

Improvement of aminotransferase levels (ALAT and ASAT) at 24 weeks (end of the treatment).

Improvement of clinical symptoms and signs at 24 weeks (end of the treatment).

Full Information

NCT ID

NCT00778843

First Posted

October 21, 2008

Last Updated

May 2, 2012

Sponsor

Catalysis SL

1. Study Identification

Unique Protocol Identification Number

NCT00778843

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Catalysis SL

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis C

Keywords

Chronic hepatitis C, Oxidative stress, Antioxidant, Cytokines, Nutritional supplement

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Viusid

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo three oral sachets daily during 24 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Viusid

Intervention Description

Viusid, three oral sachets daily during 24 weeks

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo three oral sachets daily during 24 weeks

Primary Outcome Measure Information:

Title

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

Title

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 Outcome Measure Information:

Title

Improvement of aminotransferase levels (ALAT and ASAT) at 24 weeks (end of the treatment).

Time Frame

6 months

Title

Improvement of clinical symptoms and signs at 24 weeks (end of the treatment).

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eduardo Vilar Gomez, Ph.D

Organizational Affiliation

National Institute of Gastroenterology

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Institute of Gastroenterology

City

Vedado

State/Province

Havana

ZIP/Postal Code

10400

Country

Cuba

12. IPD Sharing Statement

Citations:

PubMed Identifier

17311621

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.

Results Reference

result

Links:

URL

http://www.viusid.com

Description

Related Info

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

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