TAK-672
BiologicalB-Domain Deleted Recombinant Porcine Factor VIII
Other names: rpFVIII, TAK-672, Obizur
NCT Number: NCT04580407
The main aims of the study are to learn if TAK-672 can control bleeds in participants with acquired hemophilia A and if the participants have side effects from TAK-672. Acquired hemophilia A is when people's immune system attacks specific proteins, known as clotting factors, in their bodies. This is different from hemophilia A, which is a condition people are born with.
At the first visit, the study doctor will check who can take part. For those who can take part, participants will visit the clinic or hospital when they get their next bleed. They will receive TAK-672 slowly through a vein. This is called an infusion. They might need extra infusions of TAK-672 to control the bleed. After their bleed is controlled, participants will regularly visit the clinic for a check-up and to treat any further bleeds. This will happen until all participants have received their last dose of TAK-672 to control their 1st bleed. After this, all participants will visit the clinic 90 days later for a final check-up.
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Notify Me18 year and older
All sexes
Interventional
Phase 2 / Phase 3
Gunma University Hospital, Maebashi, Gunma, Japan
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
B-Domain Deleted Recombinant Porcine Factor VIII
Other names: rpFVIII, TAK-672, Obizur
Time frame: 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%'.
Time frame: 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)
If the status assessed by the investigator at the end of study treatment of initial treatment period was "successfully controlled", the participant's initial severe bleeding episode was considered as successfully controlled.
Time frame: 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
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%'. Data is reported only for the timepoints having at least one participant available for analysis.
Time frame: 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)
'Frequency of infusions ' was calculated as the 'average number of infusions per day'. 'Qualifying bleeding episode' was defined as the 'initial, severe bleeding episode'.
Time frame: 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)
'Qualifying bleeding episode' was defined as the 'initial, severe bleeding episode'. Total dose of infusions is sum of doses from start of treatment with TAK-672 for qualifying bleeding episodes until completion of the management of the bleeding.
Time frame: 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)
'Qualifying bleeding episode' was defined as the 'initial, severe bleeding episode'. If the status assessed by the investigator at the end of study treatment of initial treatment period was "successfully controlled", the participant's initial severe bleeding episode was considered as successfully controlled.
Time frame: At 0.5, 8, 16, 24, 48, 60, 96,120, and 144 hours post dose and at 1, 14, 28, 42, 56, 70, and 90 day follow-up
Percentage of participants with response to TAK-672 therapy at specified time points and eventual control of severe bleeding episodes was assessed to determine the correlation between response to TAK-672 therapy and eventual control of severe bleeding episodes. 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%'. Data is reported only for the timepoints having at least one participant available for analysis.
Time frame: 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)
Mean value of pre-infusion anti-TAK-672 antibody titers (unit: Bethesda unit per milliliters [BU/mL]) in participants with successful control of the bleeding episode was reported as a result of correlation among the pre-infusion pFVIII inhibitor titers and the eventual control of the bleeding episode in this outcome measure.
Time frame: 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)
Mean value of total dose per participant for initial treatment period (unit: units/kg per participant) in participants with successful control of the bleeding episode was reported as a results of correlation among the total dose per participant of TAK-672 and the eventual control of the bleeding episode in this outcome measure.
Time frame: 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)
Number of participants with positive response at 24 hours after the initiation of treatment in participants with successful control of the bleeding episode was reported as a results of correlation among the response at 24 hours and the eventual control of the bleeding episode. 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 investigator using 4-point rating scale (effective-partially effective-poorly effective-not effective).
Time frame: Baseline, 72 hours postdose, and at 14, 28, 42, 56, 70, and 90 days follow-up
Data is reported only for the timepoints having at least one participant available for analysis.
Time frame: Baseline, 72 hours postdose, and at 14, 28, 42, 56, 70, and 90 days follow-up
Data is reported only for the timepoints having at least one participant available for analysis.
Time frame: Pre-dose and at multiple time points post-dose (up to 24 hours) after over 48 hours from the last treatment with TAK-672
Time frame: Pre-dose and at multiple time points post-dose (up to 24 hours) after over 48 hours from the last treatment with TAK-672
Time frame: Pre-dose and at multiple time points post-dose (up to 24 hours) after over 48 hours from the last treatment with TAK-672
Time frame: Pre-dose and at multiple time points post-dose (up to 24 hours) after over 48 hours from the last treatment with the initial dose of TAK-672
Time frame: Pre-dose and at multiple time points post-dose (up to 24 hours) after over 48 hours from the last treatment with TAK-672
Time frame: 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)
Time frame: 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)
Total dose is sum of doses from start of treatment with TAK-672 until completion of hemostasis control.
Time frame: 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)
Takeda
Industry
A Phase 2/3, Open-Label, Non-controlled Study to Evaluate the Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (rpFVIII, TAK-672), in the Treatment of Serious Bleeding Episode in Japanese Subjects With Acquired Hemophilia A (AHA)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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