Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-26 @ 11:55 AM
Study NCT ID:
NCT04133259
Status:
UNKNOWN
Last Update Posted:
2020-10-20
First Post:
2019-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Efficacy and Safety of HLX10 in Chronic Hepatitis B Patients
Sponsor:
Henlix, Inc
Organization:
Study Overview
Official Title:
An Exploratory Study to Evaluate The Efficacy And Safety of HLX10, A Humanized Monoclonal Antibody Targeting Programmed Death-1 (PD-1) Protein In Chronic Hepatitis B Patients
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
RECRUITING
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 multiple-center, open-label, Phase II clinical trial to evaluate the safety and the efficacy of HLX10 in chronic hepatitis B patients.
Detailed Description:
This study is multiple-center, open-label, Phase II clinical trial and uses Simon's Two-Stage Optimal design. Subjects with chronic hepatitis B (CHB) will be enrolled sequentially and receive up to 3 doses of HLX10 at 1 mg/kg for four weeks apart.
First six subjects will be enrolled in the safety run-in period. If there are no serious adverse events noticed in these 6 subjects up to 6 weeks after the last infusion of HLX10, additional 11 subjects will be enrolled. These 17 subjects (6+11) will be evaluated for efficacy. In the second stage of trial, 27 additional subjects will be enrolled. Total 44 subjects \[stage I (n=17) + stage II (n= 27) = total (n=44)\] will be accrued in this study.
First six subjects will be enrolled in the safety run-in period. If there are no serious adverse events noticed in these 6 subjects up to 6 weeks after the last infusion of HLX10, additional 11 subjects will be enrolled. These 17 subjects (6+11) will be evaluated for efficacy. In the second stage of trial, 27 additional subjects will be enrolled. Total 44 subjects \[stage I (n=17) + stage II (n= 27) = total (n=44)\] will be accrued in this study.
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?: