Do Low High Density Lipoprotein (HDL) Levels Predict Trea... | NCT01159613

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

NCT01159613

Sponsor

Ziv Hospital

Status

Completed

Last Update Posted

Jul 9, 2010Estimated

Enrollment

80Actual

Phase

Not provided

Conditions

Chronic Hepatitis C Viral Infection

Interventions

Responders
Non Responders

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Oct 2008Actual

Completion Date

Jan 2009Actual

First Submitted Date

Jul 8, 2010

First Submission Date that Met QC Criteria

Jul 8, 2010

First Posted Date

Jul 9, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2010

Last Update Posted Date

Jul 9, 2010Estimated

Name	Class
Hillel Yafe MC Hadera	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non Responders		Non Responders	Other: Non Responders
RESPONDERS			Other: Responders

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Responders	Other	Responders	RESPONDERS
Non Responders

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sustained viral response	achieving SVR	72 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chronic HCV genotype 1 naive patients

Exclusion Criteria:

Co infection with HBV, HIV, HDV
Decompensated liver disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

chronic HCV genotype 1 naïve patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ziv medical center liver unit		Safed, Israel			Israel