Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Natural History of Hepatitis C in Patients With Normal Liver Tests

This study is ongoing, but not recruiting participants.
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 ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections
Virus Diseases processed this record on March 03, 2015