EUCTR2019-003051-11-BG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 - DHELIVER
Promethera Therapeutics0 个研究点目标入组 100 人开始时间: 2019年10月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients must fulfill all of the following criteria in order to be eligible for
- •trial enrollment:
- •1. Are adults aged between 18 and 70 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 = 5 mg/dL.
- •5. Are able to read, understand and give written informed consent.
- •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. In case of
- •hepatic encephalopathy (HE), the ICF must be signed by the patient after
- •encephalopathy improvement, if possible.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Patients presenting with any of the following criteria will not be included
- •in the study:
- •1. Have a MELD-Na score > 35.
- •2. Have underlying cirrhosis due to biliary disease.
- •3. Have underlying cirrhosis due to autoimmune hepatitis.
- •4. 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.
- •5. 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.
- •6. Have a complete portal vein thrombosis.
- •7. Have coagulation disturbances defined as:
- •o fibrinogen < 80 mg/dL
- •o platelets < 50 x 10³/mm³
- •8. Are requiring chronic dialysis therapy.
- •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.
- •10. Have a previous history of myocardial infarction and/or cardiac
- •failure, with an ejection fraction rate (EFR) = 40%.
- •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).
- •o 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 cellbased
- •19. Are accepted as High Urgency status patient by the organ allocation
- •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
- 另有 12 项未显示
研究者
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