CTIS2022-500252-28-00进行中（未招募）1 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 - HEP102
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Cellaïon SA
- 入组人数
- 134
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •1. Are adults aged between 18 and 75 years old., 2. Have an initial diagnosis of ACLF at the investigational site., 3. Have ACLF grade 1 or 2 according to the EASL-CLIF Consortium definition., 4. Have a total bilirubin more or equal 5 mg per dL., 5. 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
- •1. Have a MELD-Na score more than 35., 9. 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., 11. Have an inability to maintain mean blood pressure (BP) > 60 mmHg despite use of vasopressors., 12. Have severe pulmonary arterial hypertension defined as mean pulmonary arterial pressure (MPAP) = 45 mmHg (or right ventricular systolic pressure = 50 mmHg) by echocardiography., 13. Have hepatopulmonary syndrome., 14. Are receiving mechanical ventilation due to respiratory failure., 15. Have known or suspected hypersensitivity or allergy to any of the components of the HepaStem diluent, dimethyl sulfoxide (DMSO), or bovine serum albumin., 16. Have a history of severe allergies to drugs and/or a history of severe anaphylactic reactions., 17. 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., 18. Had a previous organ transplantation and or treatment with cell-based therapy., 19. Are accepted as High Urgency status patient by the organ allocation system., 10. Have a previous history of myocardial infarction and/or cardiac failure, with an ejection fraction rate (EFR) = 40%., 20. 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., 21. Are receiving immunosuppressive drugs, except glucocorticoids. Patients receiving glucocorticoids administered for treatment of severe alcoholic hepatitis may participate in the study., 22. Have a contraindication to or are unwilling to take glucocorticoids to prevent infusion-like reaction., 23. Have persistently positive blood cultures despite 48 hours of antibiotic therapy that indicates uncontrolled bacterial infection., 24. Have diagnosis of invasive aspergillosis., 25. Have known infection with human immunodeficiency virus (HIV)., 26. Have a history of hepatitis D virus infection., 28. Are women of childbearing potential who decline to use highly effective (authorized) methods of contraception during the study., 27. Are women who have been using hormonal oral contraception within 8 weeks of study entry., 29. Are pregnant (i.e., positive blood or urine b-hCG test) or nursing/breastfeeding., 2. Have underlying cirrhosis due to biliary disease., 30. 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., 31. 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., 32. Are persons performing mandatory military service, persons deprived of liberty, per
研究者
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