EUCTR2019-003051-11-FR进行中（未招募）1 期
Randomized, placebo-controlled, double blind, multi-centre Phase IIbstudy to evaluate the efficacy and safety of HepaStem in patients withAcute on Chronic Liver Failure (ACLF) - DHELIVER - HEP102 - DHELIVER
Promethera Biosciences0 个研究点目标入组 363 人开始时间: 2021年1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
- 363
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 fulfil all of the following criteria in order to be eligible for
- •trial enrolment:
- •1. Adult aged 18 years and above.
- •2. Initial diagnostic of ACLF, at the investigational site, maximum 3 days
- •before signature of the ICF.
- •3. Patient with Acute on Chronic Liver Failure Grade 1 or 2 according to the CLIF definition*.
- •4. Bilirubin value = 5 mg/dL.
- •5. Signed Informed Consent.
- •N.B: In case of hepatic encephalopathy, if the patient is not able to fully
- •understand the study based on the investigator's judgment, the
- •Informed Consent must be signed by a patient's legal or authorized
- •representative according to local regulation, and by the patient, if
- •possible, after encephalopathy improvement.
- •* ACLF grading is based on the number of organ failure as defined per
- •the CLIF-OF score (Arroyo et al. 2015);
- •http://www.efclif.com/scientific-activity/score-calculators/clif-c-aclf
- •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 290
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 73
排除标准
- •Patients presenting with any of the following will not be included in the
- •1. ACLF grade 3.
- •2. Active uncontrolled bleeding or patient with high risk of short term
- •bleeding up to investigator's judgment.
- •3. Model for End-Stage Liver Disease (MELD) score > 35.
- •4. 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.
- •5. Mechanical ventilation due to respiratory failure, except for hepatic
- •encephalopathy.
- •6. Inability to maintain mean BP > 60 despite use of vasopressors.
- •7. Patients receiving immunosuppressive drugs, except glucocorticoids.
- •8. Thrombosis of portal vein.
- •9. Underlying cirrhosis due to biliary disease (primary sclerosing
- •cholangitis, primary biliary cholangitis…).
- •10. Underlying cirrhosis due to autoimmune hepatitis.
- •11. Coagulation disturbances defined as (Drolz et al. 2016; Nadim et al.
- •a. fibrinogen < 80 mg/dL
- •b. platelets < 50 x 10³/mm³
- •12. Uncontrolled bacterial infection upon judgment of the investigator.
- •13. Proven or probable invasive aspergillosis (Gustot et al. 2014).
- •14. Major invasive procedure within 2 weeks before the infusion. These
- •are open surgeries (the proper healing of the scar should be verified by
- •the investigator). N.B.: Liver biopsy (trans jugular or percutaneous),
- •paracentesis, TIPS are not considered as a major invasive procedure.
- •15. Previous organ transplantation and/or treatment with cells.
- •16. Previous hepatectomy.
- •17. Severe pulmonary arterial hypertension defined as mean pulmonary arterial pressure (MPAP) =45 mmHg.
- •18. Hepatopulmonary syndrome.
- •19. Known or suspected hypersensitivity or allergy to any of the
- •components of the HepaStem Diluent (human albumin, heparin sodium
- •and sodium bicarbonate, DMSO), bovine serum, or a history of multiple
- •and/or severe allergies to drugs or foods or a history of severe
- •anaphylactic reactions.
- •20. Patients with active cancer or history of cancer unless adequately
- •treated and/or in complete remission for five or more years.
- •21. Hepatocellular carcinoma.
- •22. On haemodialysis due to chronic kidney disease.
- •23. Known infection with human immunodeficiency virus (HIV).
- •24. Pregnancy (negative ß-HCG test required) and nursing women, or
- •women with childbearing potential who decline to use highly effective
- •contraception methods during the study. Authorized methods of
- •contraception are listed in Section 10.14.2.
- •25. Participation in any other interventional study within the last 4
- •weeks, or participation and/or under follow-up in another clinical trial.
- •26. Any significant medical or social condition or disability that, in the
- •Investigator's opinion, may warrant a specific treatment, or may
- •interfere with the patient's optimal participation or compliance with the
- •study procedures.
- 另有 8 项未显示
研究者
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