Status:
COMPLETED
Prediction of Significant Hepatic Fibrosis in HCV Carriers With PNALT by SAPI- A Validation Study
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Chronic Hepatitis C
Hepatic Fibrosis
Eligibility:
All Genders
18-70 years
Brief Summary
The purpose of the study is to validate the diagnostic accuracy and reproducibility of SAPI to predict significant hepatic fibrosis in HCV patients with PNALT who are scheduled to receive combination ...
Detailed Description
Hepatitis C virus (HCV) infection is a major health problem, affecting 170 million persons worldwide. Approximately 25-30% of patients with chronic hepatitis C have persistently normal alanine aminotr...
Eligibility Criteria
Inclusion
- Age older than 18 years
- HCV RNA and anti-HCV positivity for more than 6 months
- 4 consecutive normal ALT values (\< 40 IU/L for men and \< 34 IU/L for women)at 3 months apart over a period of 12 months
Exclusion
- HBV and HCV co-infection
- HBV and HIV co-infection
- History of heavy alcohol use (\> 50 gram/day)
- Autoimmune liver diseases
- Metabolic liver diseases
- Presence of hepatocellular carcinoma
- Bleeding tendency
- Decline liver biopsies
Key Trial Info
Start Date :
April 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00466271
Start Date
April 1 2007
End Date
December 1 2008
Last Update
December 23 2008
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100