2022-500252-28-00已完成2 期
Randomized, placebo-controlled, double blind, multi-centre Phase IIb stuDy to evaluate the efficacy and safety of HepaStem in patients with Acute on Chronic Liver Failure (ACLF) – DHELIVER
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Cellaïon SA
- 入组人数
- 132
- 主要终点
- Survival at Day 90: Whether the patients are still alive will be recorded up to Day 90. Time and reason of death will be recorded.
研究概览
简要总结
The primary objective is to demonstrate the efficacy of 2 infusions (i.v.) of HepaStem at 1.0 million cells per kg (7-day interval) on the overall survival proportion 90 days post-first infusion.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Are adults aged between 18 and 75 years old.
- •Have an initial diagnosis of ACLF at the investigational site.
- •Have ACLF grade 1 or 2 according to the EASL-CLIF Consortium definition.
- •Have a total bilirubin more or equal 5 mg per dL.
- •Are able to read, understand and give written informed consent. Only in case of hepatic encephalopathy (HE) due to ACLF, if the patient is unable to fully understand the study and based on the investigator’s judgment, the ICF must be signed by a legal or authorized representative of the patient according to local regulation. After encephalopathy improvement, if possible, the ICF must be signed by the patient.
排除标准
- •Have a MELD-Na score more than
- •Have had a cerebrovascular, myocardial, limb arterial thrombotic event, or history for both thrombotic and hemorrhagic cerebrovascular events within 12 months prior to the Screening and not considered stabilized by the investigator.
- •Have an inability to maintain mean blood pressure (BP) > 60 mmHg despite use of vasopressors.
- •Have severe pulmonary arterial hypertension defined as mean pulmonary arterial pressure (MPAP) ≥ 45 mmHg (or right ventricular systolic pressure ≥ 50 mmHg) by echocardiography.
- •Have hepatopulmonary syndrome.
- •Are receiving mechanical ventilation due to respiratory failure.
- •Have known or suspected hypersensitivity or allergy to any of the components of the HepaStem diluent, dimethyl sulfoxide (DMSO), or bovine serum albumin.
- •Have a history of severe allergies to drugs and/or a history of severe anaphylactic reactions.
- •Have undergone a major invasive procedure within 2 weeks of randomization. These are open surgeries (the proper healing of the scar should be verified by the investigator). Liver biopsy (transjugular or percutaneous), paracentesis, and transjugular intrahepatic portosystemic shunt (TIPS) are not considered as major invasive procedures.
- •Had a previous organ transplantation and or treatment with cell-based therapy.
- •Are accepted as High Urgency status patient by the organ allocation system.
- •Have a previous history of myocardial infarction and/or cardiac failure, with an ejection fraction rate (EFR) ≤ 40%.
- •Have active primary or recurrent malignant disease (including hepatocellular carcinoma) or have been in remission from clinically significant malignancy for < 5 years. o Patients with cervical carcinoma in situ that has been resected with no evidence of recurrence or metastatic disease for at least 3 years may participate in the study. o Patients with basal cell or squamous epithelial skin cancers that have been completely resected with no evidence of recurrence for at least 3 years may participate in the study.
- •Are receiving immunosuppressive drugs, except glucocorticoids. Patients receiving glucocorticoids administered for treatment of severe alcoholic hepatitis may participate in the study.
- •Have a contraindication to or are unwilling to take glucocorticoids to prevent infusion-like reaction.
- •Have persistently positive blood cultures despite 48 hours of antibiotic therapy that indicates uncontrolled bacterial infection.
- •Have diagnosis of invasive aspergillosis.
- •Have known infection with human immunodeficiency virus (HIV).
- •Have a history of hepatitis D virus infection.
- •Are women of childbearing potential who decline to use highly effective (authorized) methods of contraception during the study.
- •Are women who have been using hormonal oral contraception within 8 weeks of study entry.
- •Are pregnant (i.e., positive blood or urine b-hCG test) or nursing/breastfeeding.
- •Have underlying cirrhosis due to biliary disease.
- •Have participated in any other interventional study within 4 weeks of study entry, or participation and/or under follow-up in another interventional clinical trial.
- •Have any significant medical or social condition or disability that, in the investigator’s opinion, may interfere with the patient’s optimal participation or compliance with the study procedures.
- •Are persons performing mandatory military service, persons deprived of liberty, persons who, due to a judicial decision, cannot take part in clinical trials, and persons, who due to their age, disability or state of health are reliant on care and for that reason accommodated in residential care institutions, that is accommodations providing an uninterrupted assistance for persons who necessitate such assistance, are in a situation of subordination or factual dependency and therefore may require specific protective measures.
- •Are employees of the Sponsor or investigator, or otherwise dependent on them.
- •Have underlying cirrhosis due to autoimmune hepatitis.
- •Have active bleeding at a non-compressible site or at a compressible site that, in the opinion of the investigator, poses an unacceptable risk for the patient's participation in the study.
- •Have received treatment for bleeding complications during the current hospitalization and has a persistent high risk for re-bleeding that, in the opinion of the investigator, poses an unacceptable risk for the patient's participation in the study.
- •Have a complete portal vein thrombosis.
- •Have coagulation disturbances defined as: fibrinogen < 80 mg/dL; platelets < 50 x 10³/mm³
- •Are requiring chronic dialysis therapy.
结局指标
主要结局
Survival at Day 90: Whether the patients are still alive will be recorded up to Day 90. Time and reason of death will be recorded.
Survival at Day 90: Whether the patients are still alive will be recorded up to Day 90. Time and reason of death will be recorded.
次要结局
- Liver transplant-free survival (TFS) at Day 90.
- TFS at Day 90 while free of ACLF.
- TFS at Day 90 with MELD-Na score below 15.
- Duration of overall hospitalization and hospitalization in ICU and non- ICU during the index hospitalization up to Day 90.
- Number, nature, severity, seriousness and relationship of AEs during the whole study. This includes but is not limited to clinically changes in clinical examinations, vital signs, laboratory tests, and imaging.
- Occurrence of systemic infection (sepsis shock, bacteremia, invasive fungal infection).
- Presence of anti-HLA Abs and donor-specific Abs (DSA) (thresholds more 1500 mean fluorescence intensity [MFI] and more than 5000 MFI).
- Quantitative measurement of coagulation parameters: PT, INR, aPTT, fibrinogen, platelets, D-dimer.
- Any change in laboratory data at all visits, including data on serology, hematology, biochemistry. Abnormal laboratory results will only constitute an AE, and will be reported as such, if they are considered abnormal within the pathology of this study population.
- Physical examination and vital signs at all visits.
研究者
Regulatory Affairs
Scientific
Cellaïon SA
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