NCT01159613

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2010

Completed
Last Updated

July 9, 2010

Status Verified

July 1, 2010

Enrollment Period

6 months

First QC Date

July 8, 2010

Last Update Submit

July 8, 2010

Conditions

Chronic Hepatitis C Viral Infection

Keywords

SVRCholesterol levelfibrosis scoreHDL

Outcome Measures

Primary Outcomes (1)

  • sustained viral response

    achieving SVR

    72 weeks

Study Arms (2)

Non Responders

Non Responders

Other: Non Responders

RESPONDERS

Other: Responders

Interventions

RespondersOTHER

Responders

RESPONDERS
Non RespondersOTHER

Non Responders

Non Responders

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

chronic HCV genotype 1 naïve patients

You may qualify if:

  • Chronic HCV genotype 1 naive patients

You may not qualify if:

  • Co infection with HBV, HIV, HDV
  • Decompensated liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziv medical center liver unit

Safed, Israel, Israel

Location

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

July 8, 2010

First Posted

July 9, 2010

Study Start

April 1, 2008

Primary Completion

October 1, 2008

Study Completion

January 1, 2009

Last Updated

July 9, 2010

Record last verified: 2010-07

Locations

IL(1)