Do Low High Density Lipoprotein (HDL) Levels Predict Treatment Outcome in Patients With Chronic Hepatitis C Viral Infection?

This study has been completed.

Sponsor:

Collaborator:

Hillel Yafe MC Hadera

Information provided by:

Ziv Hospital

ClinicalTrials.gov Identifier:

NCT01159613

First received: July 8, 2010

Last updated: NA

Last verified: July 2010

History: No changes posted

Tracking Information
First Received Date ^ICMJE	July 8, 2010
Last Updated Date	July 8, 2010
Start Date ^ICMJE	April 2008
Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 8, 2010)	sustained viral response [ Time Frame: 72 weeks ] [ Designated as safety issue: No ] achieving SVR
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Do Low High Density Lipoprotein (HDL) Levels Predict Treatment Outcome in Patients With Chronic Hepatitis C Viral Infection?
Official Title ^ICMJE	Do Low HDL Levels Predict Treatment Outcome in Patients With Chronic Hepatitis C Viral Infection?
Brief 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.
Detailed 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).
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	chronic HCV genotype 1 naïve patients
Condition ^ICMJE	Chronic Hepatitis C Viral Infection
Intervention ^ICMJE	Other: Responders Responders Other: Non Responders Non Responders
Study Group/Cohort (s)	Non Responders Non Responders Intervention: Other: Non Responders RESPONDERS Intervention: Other: Responders
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	80
Completion Date	January 2009
Primary Completion Date	October 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Chronic HCV genotype 1 naive patients Exclusion Criteria: Co infection with HBV, HIV, HDV Decompensated liver disease
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT01159613
Other Study ID Numbers ^ICMJE	HDL + HCV
Has Data Monitoring Committee	Yes
Responsible Party	Liver Clinic, Ziv medical center
Study Sponsor ^ICMJE	Ziv Hospital
Collaborators ^ICMJE	Hillel Yafe MC Hadera
Investigators ^ICMJE	Not Provided
Information Provided By	Ziv Hospital
Verification Date	July 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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