Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04580407 | Study of TAK-672 in Participants With Acquired Hemophilia A | PHASE2 | COMPLETED | 5 | — | — | Apr 9, 2021 | Nov 29, 2022 | Dec 2, 2024 | 9 | Japan |
Percentage of severe bleeding episodes with demonstrated response to TAK-672 therapy at 24 hours after the initiation of treatment was assessed by using a well-defined 4-point ordinal scale - A 'positive response' was defined as 'effective' (bleeding stopped with clinical control and FVIII:C levels of 50% or higher ) or 'partially effective' (bleeding reduced with clinical stabilization and FVIII:C levels of 20% or higher) control of bleeding, as determined by the investigator using a 4-point rating scale (effective - partially effective - poorly effective - not effective). 'Poorly effective' was defined as 'bleeding slightly reduced or unchanged and FVIII:C levels of less than 50%'. 'Not effective' was defined as 'bleeding worsening and FVIII:C levels of less than 20%'.
| Arm | Type | Description |
|---|---|---|
| TAK-672 | EXPERIMENTAL | TAK-672 was administered at an initial dose of 200 U/kg with IV infusion at a rate of 1-2 mL/min at Day 1. Subsequent doses were determined based on the post-infusion FVIII:C achieved after the most recent dose given, the target FVIII:C, and pFVIII inhibitor titer. |
| Name | Type | Description |
|---|---|---|
| TAK-672 | BIOLOGICAL | B-Domain Deleted Recombinant Porcine Factor VIII |
Inclusion Criteria: 1. Male or female Japanese participants of \>=18 years of age. 2. Participants who (or their legally authorized representatives) have provided his/her written informed consent form prior to any study-related procedures and study product administration. 3. Participants with a dia...