A 60 month, single-arm, proof-of-concept study to induce allogeneic tolerance in deceased donor liver transplant recipients using siplizumab, an anti-CD2 antibody in combination with cyclophosphamide and splenectomy.

Status

Suspended

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508397-29-00

Acronym

TCD601G201

Enrollment

Registered

2024-07-23

Start date

2022-06-29

Completion date

Unknown

Last updated

2025-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prophylaxis against liver allograft rejection following tolerance induction

Brief summary

The proportion of patients who are free from immunosuppression at Month 30 post-transplant.

Detailed description

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))

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The proportion of patients who are free from immunosuppression at Month 30 post-transplant.	—

Secondary

Measure	Time frame
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))	—

Countries

Sweden

Outcome results