Prediction of Significant Hepatic Fibrosis in HCV Carriers With PNALT by SAPI- A Validation Study

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00466271
First received: April 24, 2007
Last updated: December 21, 2008
Last verified: December 2008
  Purpose

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 therapy with pegylated interferon plus ribavirin and percutaneous liver biopsies.


Condition
Chronic Hepatitis C
Hepatic Fibrosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Prediction of Significant Hepatic Fibrosis in HCV Carriers With Persistently Normal Alanine Aminotransferase Levels by Splenic Arterial Pulsatility Index- A Validation Study

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Enrollment: 102
Study Start Date: April 2007
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
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 aminotransferase (PNALT) levels, and another 40% have ALT levels less than twice the upper limit of normal (ULN). PNALT is generally defined as at least three normal ALT levels documented at least 2 months apart over a period of 6 months. Although the natural history of HCV carriers with PNALT levels remains unclear, most of them may have mild necroinflammation with mild or no fibrosis on liver histology, and the rate of disease progression is slower than patients with elevated ALT levels. However, some patients with PNALT levels still present with advanced fibrosis or even cirrhosis. A recent study has shown that combined pegylated interferon alpha plus ribavirin treatment for HCV carriers with PNALT levels can achieve comparable sustained virological response (SVR) to those with elevated ALT levels, suggesting antiviral therapy could be initiated irrespective of ALT levels. Furthermore, patients with initial diagnosis of significant fibrosis on liver biopsies harbor higher risks to advanced fibrosis and cirrhosis, and may merit antiviral therapy to stop or delay the progression of hepatic fibrosis.

Currently, liver biopsy is recognized as the gold standard for assessing the grade of necroinflammation and stage of fibrosis before the initiation of antiviral therapy. However, it is costly and harbors risk of complications. In addition, sampling error due to the non-uniform distribution of the parenchymal damage, as well as intra- and inter-observer variability is often encountered. A noninvasive tool to evaluate liver disease activity or fibrosis stage is helpful, particularly in monitoring HCV carriers over time.

Studies assessing the usefulness of noninvasive tests to predict hepatic fibrosis were mainly performed in patients with elevated ALT levels. In patients with PNALT levels, only three studies have addressed the value of Fibroscan, Fibro Test and aspartate aminotransferase (AST) to platelet ratio index (APRI). However, Fibro Test is costly and Fibroscan has not been widely used. In addition, APRI has not been shown by other cohorts in patients with PNALT levels to possess excellent diagnostic accuracy and reproducibility (32). Currently, splenic arterial pulsatility index (SAPI) has been shown to have superior diagnostic accuracy to various biochemical indices (including APRI, API (age-platelet index), and AAR (AST to ALT ratio)) in predicting significant hepatic fibrosis in HCV carriers with PNALT. However, SAPI has not been validated in an independently prospective cohort to confirm both the diagnostic accuracy and reproducibility. Therefore, our study is aimed 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 therapy with pegylated interferon plus ribavirin and percutaneous liver biopsies.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

HCV carriers with persistently normal ALT levels who will receive percutaneous liver biopsy

Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00466271

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Director: Chen-Hua Liu, MD Department of Internal Medicine, National Taiwan Universitys Hospital
  More Information

Publications:

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00466271     History of Changes
Other Study ID Numbers: 200611011R
Study First Received: April 24, 2007
Last Updated: December 21, 2008
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Chronic hepatitis C
Persistently normal alanine aminotransferase levels
Hepatic fibrosis
Non-invasive diagnosis
Splenic arterial pulsatility index

Additional relevant MeSH terms:
Fibrosis
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Liver Cirrhosis
Hepatitis C, Chronic
Pathologic Processes
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 August 28, 2014