Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-03-11 @ 12:56 AM
Study NCT ID:
NCT03777969
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-09-06
First Post:
2018-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prediction System of Clinical Endpoint Events for Chronic Hepatitis B Patients
Sponsor:
Beijing Friendship Hospital
Organization:
Study Overview
Official Title:
Precise Prediction System for Clinical Endpoint Events of Chronic Hepatitis B Patients in the Ear of Antiviral Therapy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-09
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:
A total of 2000 chronic hepatitis B (CHB) patients with liver biopsy performed at least 1 year after antiviral therapy are enrolled. All the patients will receive original antiviral treatment for the following 10 years. Patients will be assessed at baseline and at every six months for blood count, liver function test, alpha fetoprotein (AFP), prothrombin time, liver ultrasonography, liver stiffness measurement (LSM), Hepatitis B virus (HBV) DNA and HBV serological markers. HBV-related endpoint events, including cirrhosis decompensations (ascites, esophageal variceal bleeding and hepatic encephalopathy), hepatocellular carcinoma (HCC), liver transplantation and liver-related death, will be collected during follow-up.
Detailed Description:
No.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: