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Natural History of Hepatitis C in Patients With Normal Liver Tests

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2014 by University of California, San Francisco.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00187473
First Posted: September 16, 2005
Last Update Posted: July 22, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of California, San Francisco
  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:

Primary Outcome Measures:
  • ALT [ Time Frame: March 2015 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00187473


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

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00187473     History of Changes
Other Study ID Numbers: H10102-17633
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: July 22, 2014
Last Verified: July 2014

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

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