Prophylaxis against liver allograft rejection following tolerance induction MedDRA version: 21.1 Level: LLT Classification code 10050434 Term: Prophylaxis against liver transplant rejection System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Sponsors
ITB-MED AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult subjects aged 18-70 receiving an ABO compatible deceased donor liver transplant. 2. MELD score =65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether a siplizumab-based regimen can induce allogeneic tolerance in deceased donor liver transplant recipients.;Secondary Objective: To explore the safety of siplizumab.;Primary end point(s): The proportion of patients who are free from immunosuppression at Month 30 post-transplant. ;Timepoint(s) of evaluation of this end point: 30 months post-transplant. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Composite efficacy failure rate of treated biopsy proven acute rejection (tBPAR), graft loss or death at Month 30 - The proportion of patients who remain off immunosuppression for at least 12 months - Incidence, severity, and treatment of acute rejection (derived from the biopsy, rejection, adverse event (AE) and treatment Case Report Forms (CRFs));Timepoint(s) of evaluation of this end point: 30 months. | — |
Countries
Sweden
Contacts
Public ContactClinical Trial Information
ITB-MED AB
Outcome results
None listed