Natural History of Hepatitis C in Patients With Normal Liver Tests

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00187473
First received: September 13, 2005
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

The Major goals of this project was to assess the natural history of disease in chronic hepatitis C patients with normal ALT and to determine the virologic and host factors associated with disease severity.


Condition Intervention
Chronic Hepatitis C
Procedure: liver biopsy

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Determinants of Disease Severity in Patients With Chronic Hepatitis C and Normal Serum Aminotransferases (Normal Liver Tests)

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Enrollment: 92
Study Start Date: June 2000
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: liver biopsy
    Liver biopsy every 5 years
  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

HCV patients with normal ALT

Criteria

Inclusion Criteria:

  • Patients with chronic hepatitis C and persistently normal liver enzymes
  • able to give consent

Exclusion Criteria:

  • decompensated liver disease
  • any prior antiviral or immunosuppressive therapy
  • other liver disease besides hepatitis C
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00187473

Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Mandana Khalili, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00187473     History of Changes
Other Study ID Numbers: H10102-17633
Study First Received: September 13, 2005
Last Updated: May 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
hepatitis C
HCV
natural history

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

ClinicalTrials.gov processed this record on April 17, 2014