Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Thymoglobulin · 4 trials · 9 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Standard (tacrolimus based standard therapy without induction) |
| 2 Standard of Care | ACTIVE_COMPARATOR | Thymoglobulin with tacrolimus and corticosteroid sparing maintenance therapy |
| 1 Control | ACTIVE_COMPARATOR | Simulect (basiliximab) |
| 2 | EXPERIMENTAL | Thymoglobulin (anti-thymocyte globulin (rabbit)) |
| Dose Level 1 | EXPERIMENTAL | Thymoglobulin 2.0 mg/kg over 8 hours on day 1 and over 6 hours on days 2-4. |
| Dose Level 2 | EXPERIMENTAL | Thymoglobulin 3.0 mg/kg over 8 hours on day 1 and over 6 hours on days 2-4. |
| Dose Level 3 | EXPERIMENTAL | Thymoglobulin 4.0 mg/kg over 8 hours on day 1 and over 6 hours on days 2-4. |
| Name | Type | Description |
|---|---|---|
| Thymoglobulin | BIOLOGICAL | Antibody inductions with tacrolimus and corticosteroid sparing maintenance therapy |
| Corticosteroid | DRUG | For a minimum of 3 months |
| Tacrolimus | DRUG | Between Day 3 the last dose of Thymoglobulin |
| Mycophenolate Mofetil | DRUG | for at least 1 month posttransplant |
| Thymoglobulin [Anti-Thymocyte Globulin (Rabbit)] | DRUG | - |
| Simulect (basliximab) | DRUG | 20 mg per day on 2 days |
Inclusion Criteria: * Primary liver transplant recipient with Model for End-Stage Liver Disease (MELD) criteria documentation * Serum creatinine \> 1.5mg/dL at the time of transplant, or based on the value used to calculate the most recent pre-operative MELD Score for liver allocation * Ages greate...
Thymoglobulin is an investigational monoclonal antibody being studied for use in renal transplantation, liver dysfunction, and relapsed or refractory multiple myeloma. In clinical trials, it has been evaluated for preventing renal transplant rejection, preventing delayed graft function and acute allograft rejection in cadaveric donor renal transplantation, and for treating relapsed or refractory multiple myeloma.
Thymoglobulin is being developed by Sanofi, a company traded on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the drug's safety and efficacy in transplantation and oncology settings.
Thymoglobulin is in Phase 2 clinical development. It has completed Phase 2 trials for renal transplantation and liver dysfunction, and a Phase 1 trial for relapsed or refractory multiple myeloma. The drug remains investigational and is not approved for any use.
Thymoglobulin has been studied in several completed clinical trials. NCT00089947 evaluated it for preventing renal transplant rejection, NCT00117689 for liver transplant rejection, NCT00235300 for preventing delayed graft function in cadaveric donor renal transplantation, and NCT00545519 for relapsed or refractory multiple myeloma.
Thymoglobulin is a monoclonal antibody. Its specific molecular target has not been disclosed in the available clinical trial information, so its precise mechanism of action is not described here.
Thymoglobulin is not the same as Simulect. In clinical trial NCT00235300, Thymoglobulin was compared directly against Simulect for the prevention of delayed graft function and acute allograft rejection in renal allograft recipients, indicating they are distinct treatments.