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Natural History of Hepatitis C in Patients With Normal Liver Tests

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ClinicalTrials.gov Identifier: NCT00187473
Recruitment Status : Unknown
Verified July 2014 by University of California, San Francisco.
Recruitment status was:  Active, not recruiting
First Posted : September 16, 2005
Last Update Posted : July 22, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Chronic Hepatitis C Procedure: liver biopsy

Study Design

Study Type : Observational
Actual Enrollment : 92 participants
Observational Model: Cohort
Official Title: Determinants of Disease Severity in Patients With Chronic Hepatitis C and Normal Serum Aminotransferases (Normal Liver Tests)
Study Start Date : June 2000
Estimated Primary Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Procedure: liver biopsy
    Liver biopsy every 5 years

Outcome Measures

Primary Outcome Measures :
  1. ALT [ Time Frame: March 2015 ]

Eligibility Criteria

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

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
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 Posted: September 16, 2005    Key Record Dates
Last Update Posted: July 22, 2014
Last Verified: July 2014

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

Additional relevant MeSH terms:
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