NCT00842205

Brief Summary

In the presented project, the role of heme oxygenase 1 and 2 in the procesess associated with fibroproduction in the chronic HCV infection will be studied. Heme oxygenase expression will be evaluated by the techniques of molecular genetics and immunohistochemistry, both in the liver tissue and in peripheral blood mononuclear cells. These parameters will be correlated with basic virological and clinical characteristics of the chronic HCV infection. The investigators' expected results may help in understanding the mechanisms of fibroproduction in chronic HVC infection and, therefore, contribute to explain individual differences in the development of chronic HCV infection.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2007

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

February 12, 2009

Status Verified

February 1, 2009

Enrollment Period

2.4 years

First QC Date

February 11, 2009

Last Update Submit

February 11, 2009

Conditions

Chronic HCV InfectionNonalcoholic Steatohepatitis

Keywords

hepatitis CNASHHem OxygenaseGene polymorphism

Outcome Measures

Primary Outcomes (1)

  • 1. the relation between HO activity and basic virologic and histologic parameters in chronic HCV patients. 2. changes of HO activity within antiviral treatment 3. relation of HO gene polymorphisms to the course of disease

    from HCV transmission in each individual patient to the time of liver biopsy and begining of antiviral treatment

Secondary Outcomes (1)

  • Relation of HO gene polymorphisms and UGT1A1*28 polymorphism.

    3 years

Study Arms (2)

1 HCV positive pts

ACTIVE COMPARATOR

Patients with chronic HCV infection undergoing liver biopsy followed by antiviral treatment. peg-IFN alfa 2a 180ug s.c. QW + ribavirin 1000-1200mg p.o. daily 48weeks or peg-IFN alfa 2b 1.5 ug/kg s.c. QW + ribavirin 100-1200mg p.o. daily 48 weeks

Drug: pegylated interferonDrug: Ribavarin

2 Other liver disease

NO INTERVENTION

pts. with NASH (or other liver disease) undergoing liver biopsy.

Interventions

pegylated interferonDRUG

peg-IFN alfa 2a 180ug s.c. QW or peg-IFN alfa 2b 1.5 ug/kg s.c. QW

Also known as: Pegasys, Pegintron
1 HCV positive pts
RibavarinDRUG

ribavirin 1000-1200mg p.o. daily 48weeks or ribavirin 100-1200mg p.o. daily 48 weeks

Also known as: Copegus, Rebetol
1 HCV positive pts

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • chronic HCV infection
  • must undergo liver biopsy
  • must undergo antiviral treatment

You may not qualify if:

  • liver sample not obtained
  • blood samples for HCV testing not obtained in specified time points during antiviral therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cetral Military Hospital

Prague, 16202, Czechia

RECRUITING

Related Publications (1)

  • Urbanek P, Lenicek M, Muchova L, Subhanova I, Dusek L, Kasprikova N, Hrabal P, Bruha R, Vitek L. No association of promoter variations of HMOX1 and UGT1A1 genes with liver injury in chronic hepatitis C. Ann Hepatol. 2011 Oct-Dec;10(4):445-51.

    PMID: 21911884DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseHepatitis C

Interventions

peginterferon alfa-2apeginterferon alfa-2bRibavirin

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 11, 2009

First Posted

February 12, 2009

Study Start

January 1, 2007

Primary Completion

June 1, 2009

Study Completion

December 1, 2009

Last Updated

February 12, 2009

Record last verified: 2009-02

Locations

CZ(1)