Ignite Creation Date:
2024-05-06 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05244057
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2022-02-03
Brief Title:
A Study of Hepalatide Combined With TAF and PEG-IFN as Finite Treatment of Chronic Hepatitis B Patients
Sponsor:
Shanghai HEP Pharmaceutical Co Ltd
Organization:
Shanghai HEP Pharmaceutical Co Ltd
Study Overview
Official Title:
A Phase II of Randomized Double-blind Placebo-controlled Multi-center Study of Hepalatide for Injection Combined With Pegylated Interferon and TAF as Finite Treatment in Chronic Hepatitis B Patients
Status:
COMPLETED
Status Verified Date:
2023-12
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:
The study is designed to assess efficacy of a finitie treatment in Chronic Hepatitis B patients who had stable treatment of NAs for 2 years which is compared hepalatide in combination with Pegylated Interferon TAF with Pegylated Interferon TAF Subjects will be randomly assigned to the hepalatide or placebo groups 15 subjects in each group Subjects will receive hepalatidePegylated Interferon TAF treatment for 48 weeks or placebo PegylatedInterferon TAF treatment for 48 weeks Then stopping hepalatide and Pegylate Interferon treatments and followed with further 8 weeks follow-up
Detailed Description:
Hepalatide is a liver-targeted antiviral therapeutic for subcutaneous injection designed to treat chronic hepatitis B virus HBV infection The aim of this study is to assess efficacy of a finitie treantment that combination regimen of hepalatidehalf dose Pegylated interferon TAF as measured by the primary efficacy endpoint This study will be conducted in 3 periods Screening Period 4weeks Treatment Period 48 weeks and Follow-up FU Period 8 weeks Safety assessments will include adverse events AEs serious AEs clinical safety laboratory tests electrocardiograms ECGs vital signs ophthalmologic examinations and physical examinations Total duration of individual participation will be up to 60 weeks including screening period
Study Oversight
Has Oversight DMC:
None
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?:
None