EUCTR2021-001680-24-SE进行中（未招募）1 期
A 60 month, single-arm, proof-of-concept study to induce allogeneic tolerance in deceased donor liver transplant recipients using siplizumab, an anti-CD2 antibody in combination with cyclophosphamide and splenectomy.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ITB-MED AB
- 入组人数
- 12
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 subjects aged 18-70 receiving an ABO compatible deceased donor liver transplant.
- •2. MELD score <30 on recent evaluation within 60 days of screening
- •3. Stable cardio-pulmonary status per the judgement of the investigator and eligible for transplantation per local regulations.
- •4. EBV sero-positive.
- •5. SARS-CoV-2 negative.
- •6. Male study subjects willing to maintain barrier contraception (condom) and agree not to father a child until 12 weeks after the last dose of MMF.
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1. Use of other investigational drugs (or enrollment in another investigational drug study) within 30 days of screening or 5 half-lives of the medication, whichever is longer
- •2. History of hypersensitivity to any of the study treatments or their excipients or to drugs of similar chemical classes (e.g., siplizumab, TAC, cyclophosphamide or MMF)
- •3. End stage liver disease of autoimmune origin, including autoimmune hepatitis, primary biliary cholangitis or primary sclerosing cholangitis.
- •4. Subjects with leukopenia (WBC less than 2,000/mm3) or thrombocytopenia (platelet count < 70,000/mm3) at baseline
- •5. Sero-positive for HIV-1 or HBsAg. Subjects who are sero-positive for Hepatitis C virus are excluded without proof of sustained viral response (SVR) after anti-HCV treatment
- •6. Subjects with a history of TB or latent TB infection as detected by Quantiferon Gold Plus IGRA (or current standard interferon gamma release assay for TB)
- •7. Subjects with extrahepatic malignancy or history of same, other than basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- •8. Cardiac ejection fraction = 40% within 6 months or clinical evidence of cardiac insufficiency
- •9. Subjects who, in the opinion of the investigator, are not capable of giving informed consent for the study or who are unable or unwilling to adhere to the study requirement outlined in the protocol.
- •10. Subjects with any other clinically significant medical condition or laboratory abnormality that would, in the judgment of the investigator interfere with the subject’s ability to participate in the study.
- •11. Subjects who have received any live-attenuated vaccine within 2 months of planned transplant.
- •12. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
- •13. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant are excluded, unless they are using highly effective methods of contraception during dosing and for 24 weeks after the study medication has been stopped.
研究者
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