A Study of TCD601 in the Induction of Tolerance in de Novo Liver Transplantation
NCT ID: NCT06019507
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
12 participants
INTERVENTIONAL
2022-06-29
2029-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Arm 1
TCD601administered after liver transplant with splenectomy with cyclophosphamide and immunosuppression therapy
TCD601
Investigational Product
Cyclophosphamide
Conditioning Regimen
TAC
Immunosuppression Therapy
MMF
Immunosuppression Therapy
Corticosteroids
Immunosuppression Therapy
Interventions
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TCD601
Investigational Product
Cyclophosphamide
Conditioning Regimen
TAC
Immunosuppression Therapy
MMF
Immunosuppression Therapy
Corticosteroids
Immunosuppression Therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Subjects with a history of TB or latent TB infection
* Subjects with a history of cancer
18 Years
70 Years
ALL
No
Sponsors
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ITB-Med LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Kellie Kennon, BSN
Role: STUDY_DIRECTOR
ITB-MED
Locations
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Karolinska University Hospital
Stockholm, Huddinge, Sweden
Countries
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Other Identifiers
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TCD601G201
Identifier Type: -
Identifier Source: org_study_id