NCT00272389

Brief Summary

We hypothesized that pretreatment nonresponder and responder liver tissue would show consistent differences in gene expression levels and that these differences could be used to predict treatment outcomes and this can obviate the need of the present therapeutic trial.We are interested in conducting a retrospective study using the data of patients suffering from chronic HCV infection who were treated in our department with a combination of PEGINTERFERON and RIBAVIRIN. All these patients underwent liver biopsy prior the treatment. Based on the clinical data available it is possible to determine the responders and nonresponders to this therapy.RNA will be extracted from the liver tissue and the expression of 5 genes(IFI15,IFI616,IFI1,OAS3,OAS2 )will be checked .The prediction power of the combination of these genes in differentiating responders from nonresponders will be determined.

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 P50-P75 for all trials

Timeline
Completed

Started Mar 2006

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

January 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

January 6, 2006

Status Verified

January 1, 2006

First QC Date

January 4, 2006

Last Update Submit

January 4, 2006

Conditions

Hepatitis C Virus Chronic Infection

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • PATIENTS COMPLETING TREATMENT WITH PEGINTERFERON AND RIBAVIRIN FOR CHRONIC HCV INFECTION AND UNDERWENT LIVER BIOPSY PRIOR THERAPY ONSET

You may not qualify if:

  • TREATMENT NOT COMPLETED

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel

Location

Related Publications (1)

  • Chen L, Borozan I, Feld J, Sun J, Tannis LL, Coltescu C, Heathcote J, Edwards AM, McGilvray ID. Hepatic gene expression discriminates responders and nonresponders in treatment of chronic hepatitis C viral infection. Gastroenterology. 2005 May;128(5):1437-44. doi: 10.1053/j.gastro.2005.01.059.

    PMID: 15887125BACKGROUND

Study Officials

  • Yaron Ilan, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yaron Ilan, MD

CONTACT

00972 2 6778231ilan@hadassah.org.il

Tiberiu Hershcovici, MD

CONTACT

00 972 508573144: tiberiuh@md.huji.ac.il

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2006

First Posted

January 6, 2006

Study Start

March 1, 2006

Study Completion

May 1, 2006

Last Updated

January 6, 2006

Record last verified: 2006-01

Locations

IL(1)