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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HepaCure | Experimental | Patients will receive Hepacure treatment ffollowing the treatment of DPMAS and LPE |
|
| DPMAS and LPE | Active Comparator | Patients will receive DPMAS and LPE treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HepaCure | Combination Product | HepaCure will be administered in extracorporal dialysis following the treatment of DPMAS and LPE. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety outcome | Based on the recorded adverse events (AE), serious adverse events (SAE), adverse events of special interest (AESI), and device deficiencies (such as leakage caused by the inherent quality issues of the plasma bio-purification column), the safety from the start of the study treatment until 14 days after the end of the study treatment was evaluated.(Phase I) | From the initiation of treatment until 14 days after the end of study treatment.] |
| survival rate | The survival rate without liver transplantation at 12 weeks after the first treatment.(PhaseⅡ) Absolute change from baseline in the MELD score of subjects at week 4 after the first treatment. (PhaseⅡ) | 12 weeks after the initial treatment] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YU Chen, MD | Contact | 8610-83997599 | chybeyond@163.com |
| Name | Affiliation | Role |
|---|---|---|
| YU Chen, MD | Beijing YouAn Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing You'an Hospital affiliated to Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100069 | China |
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| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| DPMAS and LPE | Device | Using DPMAS and LPE for extracorporeal dialysis treatment. |
|