EUCTR2017-000177-37-GB进行中（未招募）1 期
ow-dose IL-2 to expand endogenous regulatory T cells and achieve tolerance in liver transplantation - LITE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 6
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 liver transplant recipients 2-6 years post-transplant and age =50 years;
- •2. Recipient of single organ transplant only;
- •3. Liver function tests: direct bilirubin and ALT <2 x ULN at the screening visit;
- •4. On calcineurin inhibitor (CNI) based IS; with or without one of the following: Low dose mycophenolic acid (= 1080 mg daily), mycophenolate mofetil (MMF = 1500 mg daily), or azathioprine (= 150 mg daily);
- •5. Provision of written informed consent.
- •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 25
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Serum positivity for HCV-RNA at screening;
- •2. Serum positivity for HIV-1 infection, HBV surface antigen or HBV-DNA at screening;
- •3. Active liver or systemic immune-mediated disease in which IS discontinuation is inadvisable (autoimmune hepatitis, primary sclerosing cholangitis, primary biliary cirrhosis);
- •4. Acute or chronic rejection within the 52 weeks prior to screening;
- •5. GFR <40 mL/min (to mitigate the risk of worsening renal failure should rejection occur and high level of CNI be required);
- •6. The need for chronic anti-coagulation that cannot be safely discontinued to safely perform for a liver biopsy;
- •7. Screening liver biopsy showing signs of clinically significant histological damage will preclude continuation in the trial;
- •8. Maintenance immunosuppressive therapy with a mTOR inhibitor (sirolimus or everolimus);
- •9. Active infection or malignancy;
- •10. Inability to comply with study directed treatment;
- •11. Any medical condition that in the opinion of the principal investigator would interfere with safe completion of the trial (including severe cardiac disease, severe respiratory disease with O2 blood saturation <92%, any other major organ dysfunction, and Eastern Cooperative Oncology Group (ECOG) performance status of ECOG > 1).
- •12. Participation in another IMP study within 3 months from consent;
- •13. Any known allergy or intolerance to the IMP components;
- •14. Any contraindication to Proleukin administration as per SmPC;
- •15. Pregnancy or lactation;
- •16. Lack of effective methods of contraception for women and men of childbearing potential (as per section 7.6 of the Protocol);
- •17. Hypersensitivity to Proleukin or to any of the excipients.
研究者
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