Expansion of endogenous regulatory T cells to achieve tolerance in liver transplantatio

Phase 1

• Conditions: Discontinuation of immunosuppression in liver transplantation; MedDRA version: 20.0Level: PTClassification code 10024714Term: Liver transplantSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2017-000177-37-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-02
• Study Completion: 2019-01-30
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified