Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:58 PM
Study NCT ID:
NCT05989958
Status:
RECRUITING
Last Update Posted:
2025-02-25
First Post:
2023-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Safety ,Tolerability and Efficacy Study of HepaCure in Chinese Subjects with Acute-On-Chronic Liver Failure
Sponsor:
Hexaell Biotech Co., Ltd.
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Controlled, Open-Label Phase 1/2 Clinical Study to Evaluate the Safety, Tolerability and Efficacy of HepaCure Plus DPMAS Versus DPMAS Alone in Chinese Subjects with Acute-On-Chronic Liver Failure
Status:
RECRUITING
Status Verified Date:
2025-02
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 is a multicenter, randomized, controlled, open-label phase 1/2 clinical study conducted in China to evaluate the efficacy, safety and tolerability of hiHep cell-based bio-artificial liver support system (HepaCure) plus DPMAS versus DPMAS alone in Chinese subjects with acute-on-chronic liver failure（ACLF）.
Phase 1 is a multicenter, open label study to evaluate the safety and tolerability of single dose and multiple doses of HepaCure with different treatment duration plus DPMAS in ACLF subjects respectively.
Phase 2 is a multicenter, randomized and controlled open label study to evaluate the efficacy, safety and tolerability of HepaCure plus DPMAS and LPE in ACLF subjects
Phase 1 is a multicenter, open label study to evaluate the safety and tolerability of single dose and multiple doses of HepaCure with different treatment duration plus DPMAS in ACLF subjects respectively.
Phase 2 is a multicenter, randomized and controlled open label study to evaluate the efficacy, safety and tolerability of HepaCure plus DPMAS and LPE in ACLF subjects
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?:
False
Is an FDA AA801 Violation?: