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Pharmacogenomics of Interferon and Ribavirin Treatment in Patients With Chronic Hepatitis C Virus Infection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Bayside Health.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University of Adelaide
Information provided by:
Bayside Health
ClinicalTrials.gov Identifier:
NCT00164073
First received: September 13, 2005
Last updated: July 31, 2007
Last verified: September 2005
History of Changes
  Purpose

The purpose of this study is to examine gene expression profiles by DNA microarray in patients who are responders and non-responders to interferon and ribavirin treatment for hepatitis C virus (HCV). Genes involved in inflammation and fibrosis and mediators of the Th-1 lymphocyte response will be looked for. It is hoped that genetic targets for future more effective and less toxic treatments will be identified.


Condition Intervention
Hepatitis C
 Procedure: Liver biopsy

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Pharmacogenomics of Interferon and Ribavirin Treatment in Patients With Chronic Hepatitis C Virus Infection

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayside Health:

Estimated Enrollment: 60
Study Start Date: February 2004
Estimated Study Completion Date: February 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HCV mono-infection, no coagulopathy and having a liver biopsy for consideration of treatment

Exclusion Criteria:

  • Infection with HIV or HBV, excess ethanol (EtOH) consumption and other diseases of the liver
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00164073

Contacts
Contact: Mark D Berzsenyi, MBBS 0417 574 015 m.berzsenyi@alfred.org.au

Locations
Australia, Victoria
Alfred Hospital Recruiting
Melbourne, Victoria, Australia, 3181
Contact: Mark D Berzsenyi, MBBS     0417 574 015     m.berzsenyi@alfred.org.au    
Principal Investigator: Mark D Berzsenyi, MBBS            
Sponsors and Collaborators
Bayside Health
University of Adelaide
Investigators
Principal Investigator: Mark D Berzsenyi, MBBS The Alfred
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00164073     History of Changes
Other Study ID Numbers: 122/03
Study First Received: September 13, 2005
Last Updated: July 31, 2007
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Bayside Health:
HCV and microarray
HCV

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Virus Diseases
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013