Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00466271
Status:
COMPLETED
Last Update Posted:
2008-12-23
First Post:
2007-04-24
Brief Title:
Prediction of Significant Hepatic Fibrosis in HCV Carriers With PNALT by SAPI- A Validation Study
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Prediction of Significant Hepatic Fibrosis in HCV Carriers With Persistently Normal Alanine Aminotransferase Levels by Splenic Arterial Pulsatility Index- A Validation Study
Status:
COMPLETED
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 therapy with pegylated interferon plus ribavirin and percutaneous liver biopsies
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None