Status:
ACTIVE_NOT_RECRUITING
A Study of TCD601 in the Induction of Tolerance in de Novo Liver Transplantation
Lead Sponsor:
ITB-Med LLC
Conditions:
Liver Transplantation
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate if treatment with a siplizumab-based regimen can induce allogeneic tolerance in liver transplant recipients.
Eligibility Criteria
Inclusion
- Able to understand the study requirements and provide written informed consent before and study assessment is performed
- Adult subjects aged 18-70 receiving an ABO compatible deceased donor liver transplant
- 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
Exclusion
- Pregnant or nursing (lactating) women
- Subjects with a history of TB or latent TB infection
- Subjects with a history of cancer
Key Trial Info
Start Date :
June 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2029
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06019507
Start Date
June 29 2022
End Date
June 1 2029
Last Update
November 27 2024
Active Locations (1)
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1
Karolinska University Hospital
Stockholm, Huddinge, Sweden