Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-26 @ 6:57 AM
Study NCT ID:
NCT07090759
Status:
RECRUITING
Last Update Posted:
2025-08-05
First Post:
2025-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Efficacy, Safety and Population Pharmacokinetics of GST-HG141 in Patients With Chronic Hepatitis B (CHB) Who Have an Inadequate Response to Antiviral Drug Treatment
Sponsor:
Fujian Akeylink Biotechnology Co., Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Trial of GST-HG141（Neracorvir）for Combination Therapy (add-on) in Patients With Inadequate Response to Antiviral Drugs in Chronic Hepatitis B (CHB)
Status:
RECRUITING
Status Verified Date:
2025-07
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:
This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial, aiming to evaluate the efficacy and safety of GST-HG141 in patients with chronic hepatitis B who have an inadequate response to antiviral drug treatment.
Detailed Description:
This study is a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial, aiming to evaluate the efficacy and safety of GST-HG141 in patients with chronic hepatitis B who have an inadequate response to antiviral drug treatment.
This research project enrolled a total of 526 CHB patients who have an inadequate response to hepatitis B antiviral treatment. They were divided into two groups, with 263 patients in each group.
The qualified participants were randomly assigned to the GST-HG141 group and the placebo group at a ratio of 1:1.
This research project enrolled a total of 526 CHB patients who have an inadequate response to hepatitis B antiviral treatment. They were divided into two groups, with 263 patients in each group.
The qualified participants were randomly assigned to the GST-HG141 group and the placebo group at a ratio of 1:1.
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?: