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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01159613
Other study ID # HDL + HCV
Secondary ID
Status Completed
Phase N/A
First received July 8, 2010
Last updated July 8, 2010
Start date April 2008
Est. completion date January 2009

Study information

Verified date July 2010
Source Ziv Hospital
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

The working hypothesis is that the low HDL serum level predict favorable response to anti viral treatment in chronic HCV (genotype 1) viral infection. This might be used to improve the rate of sustained virologic response.


Description:

Lipoproteins are closely connected to the process of hepatitis C virus (HCV) infection. Metabolic syndrome predicts negative treatment outcome in HCV infection.

Aim: to assess the association between lipids components of the metabolic syndrome and sustained viral response (SVR).


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date January 2009
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Chronic HCV genotype 1 naive patients

Exclusion Criteria:

- Co infection with HBV, HIV, HDV

- Decompensated liver disease

Study Design

Time Perspective: Prospective


Intervention

Other:
Responders
Responders
Non Responders
Non Responders

Locations

Country Name City State
Israel Ziv medical center liver unit Safed, Israel

Sponsors (2)

Lead Sponsor Collaborator
Ziv Hospital Hillel Yafe MC Hadera

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary sustained viral response achieving SVR 72 weeks No