NL-OMON55256尚未招募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
Promethera Therapeutics SA0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
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 99（—）
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.
- •Enrollment criteria
- •Patients must fulfill all of the following criteria in order to be enrolled in
- •the trial at the end of the
- •Screening period:
- •1. Have completed all the procedures required at Screening.
- •2. Are still meeting all inclusion criteria and no exclusion criteria.
- •Infusion criteria
- •On the day of randomization and infusion, patients must fulfill all of the
- •following criteria in order
- •to be infused with the IMP (HepaStem or the Placebo):
- •1. Have ACLF grade 1 or 2 (before first infusion).
- •2. Have been diagnosed with ACLF at the investigational site according to the
- •Consortium definition, no earlier than 8 days before randomization.
- •3. Have fibrinogen >= 80 mg/dL (as measured earlier on the same day before
- •4. Have platelets >= 50 x 10³/mm³ (as measured earlier on the same day before
- •5. Have no bleeding at a non-compressible site or no uncontrolled bleeding at a
- •compressible site as deemed by the investigator.
- •6. Is expected to remain hospitalized for at least 24 hours post infusion.
- •7. Have not experienced an adverse event (AE) considered related to the IMP and
- •with an outcome defining an SAE (before the second infusion)
- •If the patient does not meet the infusion criteria prior to the first infusion,
- •the patient will be
- •considered as a screening failure.
- •If the patient does not meet the infusion criteria prior to the second
- •infusion, or the infusion
- •cannot be performed within the Day 8 Visit timeframe (±2 days), the infusion
- •will not be
- •performed but the Day 8 Visit and further visits should be performed according
- •to the protocol.
- •The missing infusion will not be replaced.
排除标准
- •Patients presenting with any of the following criteria will not be included in
- •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
- •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:
- •- fibrinogen < 80 mg/dL
- •- 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
- •vasopressors.
- •12. Have severe pulmonary arterial hypertension defined as mean pulmonary
- •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 theHepaStem diluent, dimethyl sulfoxide (DMSO), or bovine serum
- •16. Have a history of severe allergies to drugs and/or a history of severe
- •anaphylactic
- •17. Have undergone a major invasive procedure within 2 weeks of randomization.
- •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
- •19. Are accepted as High Urgency status patient by the organ allocation system.
- •20. Have active primary or recurrent malignant disease (including
- •hepatocellular carcinoma)
- •or have been in remission from clinically significant malignancy for < 5 years.
- •- Patients with cervical carcinoma in situ that has been resected with no
- •of recurrence or metastatic disease for at least 3 years may participate in the
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