Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:29 PM
Study NCT ID:
NCT07183293
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-19
First Post:
2025-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study on Peginterferon Alfa-2b Combined With NAs in Compensated HBV Cirrhosis
Sponsor:
Xiamen Humanity Hospital
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Prospective Study on the Efficacy and Safety of Peginterferon Alfa-2b Combined With Nucleos(t)Ide Analogues in Patients With Compensated HBV-Related Liver Cirrhosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
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:
This study is a multicenter, randomized, prospective trial designed to evaluate the efficacy and safety of pegylated interferon α-2b (Peg-IFN-α2b) combined with nucleos(t)ide analogues (NAs) versus NAs monotherapy in patients with compensated hepatitis B cirrhosis. A total of 30 patients with compensated HBV-related cirrhosis will be enrolled and randomized in a 2:1 ratio to either Experimental Group 1 (n=20) or Experimental Group 2 (n=10). The treatment regimens consist of Peg-IFN-α2b combined with NAs (ETV/TAF/TMF/TDF) or NAs (ETV/TAF/TMF/TDF) monotherapy.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: