Liver Transplantation
Conditions
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.
Interventions
Sponsors
ITB-Med LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* Pregnant or nursing (lactating) women * Subjects with a history of TB or latent TB infection * Subjects with a history of cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Liver Transplant Recipients off of immunosuppression Therapy. | 30 months | Determine if treatment with siplizumab can induce allogeneic tolerance in liver transplant recipients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Incidence of adverse events and serious adverse events | 30 months | To explore the safety and tolerability of TCD601. |
Countries
Sweden
Outcome results
None listed