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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
Information provided by (Responsible Party):
University of California, San Francisco Identifier:
First received: September 13, 2005
Last updated: July 18, 2014
Last verified: July 2014
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

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
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Please refer to this study by its identifier: 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 Identifier: NCT00187473     History of Changes
Other Study ID Numbers: H10102-17633
Study First Received: September 13, 2005
Last Updated: July 18, 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 processed this record on May 25, 2017