Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00399815
Status:
UNKNOWN
Last Update Posted:
2009-09-18
First Post:
2006-11-14
Brief Title:
Noninvasive Evaluation of Hepatic Fibrosis in Chronic Hepatitis C
Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Organization:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2009-09
Last Known Status:
RECRUITING
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:
Chronic viral hepatitis C is a frequent liver disease It is associated with variable degree of hepatic fibrosis To date liver histology is still regarded as the gold standard to detect diagnose and quantify liver fibrosis This requires to perform a liver biopsy Severe complications are associated to this procedure in 001 to 01 of cases Because of this the repetition of the biopsy to evaluate the progression of the disease or the response to treatment poses ethical questions Also liver biopsy only explore a minimal portion of the liver and liver fibrosis which is not homogeneous may be under- or over-estimated
To avoid risks linked to invasive technique and sampling errors associated to liver biopsy efforts are being made to develop non-invasive technology to detect and quantitate liver fibrosis
In this study we will perform in patients with chronic hepatitis C serum tests fibroscan elastography of liver parenchyma determined by ultra-sounds and elastography of liver parenchyma by MRI
This study will allow
to determine whether non-invasive tests effectively measure liver fibrosis
to compare each non-invase test with results of liver biopsy
to determine whether a non-invasive test or a combination of non invasive tests may be used to accurately evaluate liver fibrosis in patients with chronic hepatitis C
To avoid risks linked to invasive technique and sampling errors associated to liver biopsy efforts are being made to develop non-invasive technology to detect and quantitate liver fibrosis
In this study we will perform in patients with chronic hepatitis C serum tests fibroscan elastography of liver parenchyma determined by ultra-sounds and elastography of liver parenchyma by MRI
This study will allow
to determine whether non-invasive tests effectively measure liver fibrosis
to compare each non-invase test with results of liver biopsy
to determine whether a non-invasive test or a combination of non invasive tests may be used to accurately evaluate liver fibrosis in patients with chronic hepatitis C
Detailed Description:
None
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