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
  Purpose

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.


Condition Intervention
Chronic Hepatitis C Viral Infection
Other: Responders
Other: Non Responders

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Do Low HDL Levels Predict Treatment Outcome in Patients With Chronic Hepatitis C Viral Infection?

Resource links provided by NLM:


Further study details as provided by Ziv Hospital:

Primary Outcome Measures:
  • sustained viral response [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
    achieving SVR


Enrollment: 80
Study Start Date: April 2008
Study Completion Date: January 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Non Responders
Non Responders
Other: Non Responders
Non Responders
RESPONDERS Other: Responders
Responders

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

chronic HCV genotype 1 naïve patients

Criteria

Inclusion Criteria:

  • Chronic HCV genotype 1 naive patients

Exclusion Criteria:

  • Co infection with HBV, HIV, HDV
  • Decompensated liver disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01159613

Locations
Israel
Ziv medical center liver unit
Safed, Israel, Israel
Sponsors and Collaborators
Ziv Hospital
Hillel Yafe MC Hadera
  More Information

No publications provided

Responsible Party: Liver Clinic, Ziv medical center
ClinicalTrials.gov Identifier: NCT01159613     History of Changes
Other Study ID Numbers: HDL + HCV
Study First Received: July 8, 2010
Last Updated: July 8, 2010
Health Authority: Israel: Ministry of Health

Keywords provided by Ziv Hospital:
SVR
Cholesterol level
fibrosis score
HDL

Additional relevant MeSH terms:
Communicable Diseases
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Infection
Virus Diseases
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on October 23, 2014