NCT00778843

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

May 4, 2012

Status Verified

May 1, 2012

Enrollment Period

7 months

First QC Date

October 21, 2008

Last Update Submit

May 2, 2012

Conditions

Chronic Hepatitis C

Keywords

Chronic hepatitis COxidative stressAntioxidantCytokinesNutritional supplement

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (2)

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

    6 months

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

    6 months

Study Arms (2)

Viusid

EXPERIMENTAL
Dietary Supplement: Viusid

Placebo

PLACEBO COMPARATOR

Placebo three oral sachets daily during 24 weeks

Other: Placebo

Interventions

ViusidDIETARY_SUPPLEMENT

Viusid, three oral sachets daily during 24 weeks

Viusid
PlaceboOTHER

Placebo three oral sachets daily during 24 weeks

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Gastroenterology

Vedado, La Habana, 10400, Cuba

Location

Related 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. doi: 10.1111/j.1478-3231.2006.01411.x.

    PMID: 17311621RESULT

Related Links

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Viusid

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Eduardo Vilar Gomez, Ph.D

    National Institute of Gastroenterology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2008

First Posted

October 23, 2008

Study Start

October 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

May 4, 2012

Record last verified: 2012-05

Locations

CU(1)