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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:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00187473
First received: September 13, 2005
Last updated: July 18, 2014
Last verified: July 2014
  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 ] [ 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
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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 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

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: July 18, 2014
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 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

ClinicalTrials.gov processed this record on December 09, 2016