EUCTR2016-001177-32-BG进行中（未招募）1 期
Multicenter Phase II Safety and Preliminary Efficacy Study of two dose regimens of HepaStem in Patients with Acute on Chronic Liver Failure
Promethera Biosciences0 个研究点目标入组 21 人开始时间: 2018年4月12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
- 21
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
- •1. Adult aged between 18 and 70 years old.
- •2. Informed Consent.
- •N.B: In case of hepatic encephalopathy, if the patient is not able to
- •understand the study based on the investigator's judgment, the
- •Informed Consent must be signed by patient's legal representative
- •according to local regulation, and by the patient, if possible, after
- •encephalopathy improvement.
- •3. Cirrhosis as diagnosed by (1) liver histology or (2) by clinical and
- •imaging examination (may include fibroscan).
- •4. Patient with Acute Decompensation of cirrhosis
- •5. Serum total Bilirubin = 6 mg/dL (=100 umol/L)
- •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 18
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •1. Thrombosis of the portal vein.
- •2. Recurrent or ongoing thrombotic events or patients considered with
- •high risk of thrombosis at the time of infusion.
- •Any thrombosis history should be discussed with the medical monitor
- •before exclusion / inclusion in the study, in a case by case discussion.
- •3. Ongoing uncontrolled bleeding.
- •4. Septic shock or non-controlled bacterial infection defined as persistent
- •clinical signs of infection despite adequate antibiotic therapy for more
- •5. Clinical evidence of Aspergillus infection.
- •6. Circulatory failure defined by inability to maintain a mean blood pressure =70 despite use of vasopressors.
- •7. Mechanical ventilation due to respiratory failure.
- •8. Coagulation disorders defined as:
- •Fibrinogen < 80 mg/dL
- •Platelets < 40.000/mm3
- •9. Major invasive procedure within 4 weeks before the infusion (within
- •1week for minor invasive procedure such as e.g. transjugular liver
- •biopsy). The proper healing of the puncture site should be verified by the
- •investigator.
- •10. Treatment with corticosteroids for acute liver disease less than 1 day
- •before the start of the screening period.
- •11. MELD score > 35.
- •12. Previous organ transplantation and/or ongoing immunosuppressive
- •treatments.
- •13. Postoperative-decompensation following hepatectomy.
- •14. Renal failure due to chronic kidney disease.
- •15. Clinically significant left-right cardiac shunt.
- •16. Known or suspected hypersensitivity or allergy to any of the
- •components of the HepaStem Diluent (human albumin, heparin sodium
- •and sodium bicarbonate) or a history of multiple and/or severe allergies
- •to drugs or foods or a history of severe anaphylactic reactions.
- •17. Malignancies, other than curatively treated skin cancer, unless a
- •complete remission over 5 years. In case of suspicion of HCC, all exam
- •should be done to confirm or not the diagnosis prior enrolment.
- •18. Refusal of abstinence from alcohol for at least 5 weeks from the
- •study enrolment.
- •19. Pregnancy (negative ß-HCG test required) or women with
- •childbearing potential who decline to use reliable contraceptive methods
- •during the study.
- •20. Participation to any other interventional study within the last 4
- •21. 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.
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