Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BT524 · 2 trials · 4 indications
Intra-operative blood loss as measured by amount of blood from blood suction unit and amount of blood from surgical cloths and compresses.
T1/2 of fibrinogen antigen was determined from samples taken at several time points during the 14 day sampling period. T1/2 was derived from time-concentration profiles using adapted methodology (non-compartmental analysis, compartment analysis, or population modeling, as appropriate/ required).
Time of occurence of Cmax relative to dosing (Tmax) for fibrinogen antigen was determined from samples taken at several time points during the 14 day sampling period. Tmax was derived from time-concentration profiles using adapted methodology (non-compartmental analysis, compartment analysis, or population modeling, as appropriate/required).
Maximum observed plasma concentration (Cmax) for fibrinogen antigen was determined from samples taken at several time points during the 14 day sampling period. Cmax was derived from time-concentration profiles using adapted methodology (non-compartmental analysis, compartment analysis, or population modeling, as appropriate/ required).
AUC0-tz: Area under the time course of the plasma concentrations calculated from time zero up to the last quantifiable plasma concentration for fibrinogen antigen, was determined from samples taken at several time points during the 14 day sampling period. AUC0-tz was derived from time-concentration profiles using adapted methodology (noncompartmental analysis, compartment analysis, or population modeling, as appropriate/ required).
AUCextr: extent of AUC extrapolation beyond last concentration for fibrinogen antigen, was determined from samples taken at several time points during the 14 day sampling period. AUCextr was derived from time-concentration profiles using adapted methodology (non-compartmental analysis, compartment analysis, or population modeling, as appropriate/ required).
AUC0-∞: AUC from time 0 to infinity for fibrinogen antigen, was determined from samples taken at several time points during the 14 day sampling period. AUC0-∞ was derived from time-concentration profiles using adapted methodology (non-compartmental analysis, compartment analysis, or population modeling, as appropriate/ required).
MRT0-∞: Mean Residence Time (MRT) extrapolated to infinity for fibrinogen antigen was determined from samples taken at several time points during the 14 day sampling period. MRT0-∞ was derived from time-concentration profiles using adapted methodology (non-compartmental analysis, compartment analysis, or population modeling, as appropriate/ required).
CL: Total clearance (CL) for fibrinogen antigen was determined from samples taken at several time points during the 14 day sampling period. CL was derived from time-concentration profiles using adapted methodology (non-compartmental analysis, compartment analysis, or population modeling, as appropriate/ required).
Vdss: Volume of distribution at presumed steady-state for fibrinogen antigen was determined from samples taken at several time points during the 14 day sampling period. Vdss was derived from time-concentration profiles using adapted methodology (non-compartmental analysis, compartment analysis, or population modeling, as appropriate/ required).
Vdss per kg BW: Volume of distribution at presumed steady-state per kg bodyweight for fibrinogen antigen was determined from samples taken at several time points during the 14 day sampling period. Vdss per kg BW was derived from time-concentration profiles using adapted methodology (non-compartmental analysis, compartment analysis, or population modeling, as appropriate/ required).
IR is the dose-adjusted maximum fibrinogen increase in plasma within 4 hours after the end of infusion.
CIR: maximum fibrinogen increase in plasma within 4 hours after the end of infusion divided by the maximum theoretical fibrinogen increase
| Arm | Type | Description |
|---|---|---|
| BT524 | EXPERIMENTAL | Investigational Human Fibrinogen Concentrate |
| Fresh Frozen Plasma (FFP)/Cryoprecipitate (Cryo) | ACTIVE_COMPARATOR | Standard of Care |
| Name | Type | Description |
|---|---|---|
| BT524 | BIOLOGICAL | BT524 was administered intravenously at a patient specific dosage depending on the type of surgery, the extent of bleeding and the subject's clinical condition. |
| FFP/Cryo | BIOLOGICAL | FFP/Cryo was administered intravenously; dosage according to local standards. FFP, 15 mL per kg body weight (BW); Cryoprecipitate, fixed dose of 10 units. |
| BT524 (Part I) | DRUG | Single intravenous infusion of 70 mg BT524 per kg body weight. |
| BT524 (Part II) | DRUG | Single or repetitive intravenous infusion(s) of BT524, depending on the severity of the disorder, location and extent of the bleeding and patient's clinical condition. Dosage based on individual body weight and fibrinogen level. |
Inclusion Criteria: At screening: 1. Written informed consent 2. Subjects scheduled for elective major spinal surgery or cytoreductive pseudomyxoma peritonei (PMP) surgery with expected major blood loss 3. Male or female, aged ≥ 18 years 4. No increased bleeding risk as assessed by standard coagul...
BT524 is an investigational monoclonal antibody being developed for congenital afibrinogenemia and bleeding disorders. It is also studied in congenital hypofibrinogenemia and acquired hypofibrinogenemia. The drug is in Phase 3 clinical development for these hematology conditions.
BT524 is being developed by Icon Plc, a biopharmaceutical company traded on the NASDAQ under the ticker ICLR. The company is conducting Phase 3 clinical trials to evaluate the drug's pharmacokinetics, efficacy, and safety in patients with congenital fibrinogen deficiency.
BT524 is in Phase 3 clinical development. It is an investigational drug, not yet approved by regulatory authorities. Two Phase 3 trials have been completed, with a total enrollment of 222 patients across studies in congenital afibrinogenemia, hypofibrinogenemia, and acquired bleeding disorders.
BT524 has been studied in two completed Phase 3 trials. NCT02065882 evaluated pharmacokinetics, efficacy, and safety in patients with congenital fibrinogen deficiency, enrolling 67 participants. NCT03444324 assessed an adjusted fibrinogen replacement strategy in 222 patients with bleeding disorders and acquired hypofibrinogenemia.
BT524 is the primary name for this investigational monoclonal antibody. No alternative names have been reported for the drug in clinical trial registrations. It is being studied under the identifier BT524 across multiple Phase 3 trials for fibrinogen-related bleeding conditions.
BT524 is a monoclonal antibody designed to address fibrinogen deficiency. It is being studied in conditions such as congenital afibrinogenemia, where the body lacks functional fibrinogen, a protein essential for blood clotting. The drug aims to manage bleeding episodes in these patients.