The Safety ,Tolerability and Efficacy Study of HepaCure in Chinese Subjects with Acute-On-Chronic Liver Failure

Recruiting Phase 1 Phase 2 Interventional Study
Acute on Chronic Hepatic Failure Liver Failure Hepatitis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
92 (estimated)
Sponsor
Hexaell Biotech Co., Ltd. · Industry
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About This Trial
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 s…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Able to communicate effectively with investigators and sign the informed consent form (ICF) voluntarily. 2. Age: ≥ 18 years and ≤ 65 years. 3. Body weight: ≥ 40kg; 4. Met the criteria of ACLF in the early and middle stages in screening period (Guidelines for the Diagnosis and…
Contacts

YU Chen, MD

8610-83997599

chybeyond@163.com

CONTACT