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TAK-672

Phase 2

Acquired Hemophilia A | Monoclonal antibody | Hematology |Takeda Pharmaceutical Company Limited|Last Updated: Dec 2, 2024

Success Probability

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment5

FDA Designations

No designations recorded

Clinical trial landscape

TAK-672 · 1 trial · 1 indication

Phase 2 1
NCT04580407Study of TAK-672 in Participants With Acquired Hemophilia AAcquired Hemophilia A
COMPLETED5 Analytics
PHASE2COMPLETED
Study of TAK-672 in Participants With Acquired Hemophilia A
Acquired Hemophilia AUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With Severe Bleeding Episodes Who Demonstrated Response to TAK-672 Therapy at 24 Hours After the Initiation of Treatment
24 hours after the initial dose of TAK-672

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%'.

Secondary Endpoints

Percentage of Participants With Severe Bleeding Episodes Successfully Controlled With TAK-672 Therapy, as Assessed by the Investigator
From first dose of study drug up to 90 days after the last dose of study drug or until discontinued (Up to 95 days as a maximum)
Percentage of Participants With Bleeding Episodes Responsive to TAK-672 Therapy at Designated Assessment Time Points After the Initiation of Therapy, as Assessed by the Investigator
At 0.5, 8, 16, 24, 48, 60, 96, and 120 hours post dose and at 1, 14, 28, 42, 56, 70, and 90 day follow-up
Frequency of Infusions Per Participant of TAK-672 Required to Successfully Control Qualifying Bleeding Episodes
From first dose of study drug up to 90 days after the last dose of study drug or until discontinued (Up to 95 days as a maximum)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TAK-672EXPERIMENTALTAK-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.

Interventions

NameTypeDescription
TAK-672BIOLOGICALB-Domain Deleted Recombinant Porcine Factor VIII
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

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...

Countries:Japan
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Frequently asked questions about TAK-672

What is TAK-672 used for?

TAK-672 is an investigational monoclonal antibody being developed for the treatment of acquired hemophilia A, a rare bleeding disorder. It is currently in Phase 2 clinical development and has been studied in a completed clinical trial.

Who makes TAK-672?

TAK-672 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The drug is an investigational monoclonal antibody for acquired hemophilia A and is currently in Phase 2 clinical development.

What phase is TAK-672 in?

TAK-672 is in Phase 2 clinical development. It is an investigational monoclonal antibody for acquired hemophilia A and has not been approved by regulatory authorities. One Phase 2 trial of TAK-672 has been completed.

What clinical trials is TAK-672 in?

TAK-672 has been studied in a completed Phase 2 clinical trial with the identifier NCT04580407. This trial, titled "Study of TAK-672 in Participants With Acquired Hemophilia A," enrolled 5 participants in Japan and included adults aged 18 years and older.

Is TAK-672 a monoclonal antibody?

Yes, TAK-672 is a monoclonal antibody. It is being developed by Takeda Pharmaceutical Company Limited for the treatment of acquired hemophilia A and is currently in Phase 2 clinical development.