Ignite Creation Date:
2024-05-06 @ 1:57 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01938781
Status:
COMPLETED
Last Update Posted:
2018-07-27
First Post:
2013-09-05
Brief Title:
Optimized Treatment and Regression of HBV-induced Liver Fibrosis
Sponsor:
Beijing Friendship Hospital
Organization:
Beijing Friendship Hospital
Study Overview
Official Title:
Optimized Treatment and Regression of HBV-induced Liver Fibrosis
Status:
COMPLETED
Status Verified Date:
2018-07
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:
Patients with chronic hepatitis B histologically confirmed of liver fibrosis S2S3 similar to metavir F2F3 Ishak 234 are randomly assigned in a 11 ratio One arm is entecavir alone for 2 years the other is entecavir alone for the first 05 year entecavir plus pegylated interferon peg-IFN for 1 year entecavir for another additional 05 year Patients will be assessed at baseline at every six months for blood count liver function test HBVDNA AFP prothrombin time thyroid function liver ultrasonography and Fibroscan The second liver biopsy will be performed to evaluate regression rate of liver fibrosis 15 years after initial therapy
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