A Study of TAK-660 in Surgical Procedures for People With Hemophilia A.

Adynovate Special Drug Use Result Survey (Perioperative Administration)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04941898

Enrollment

Registered

2021-06-28

Start date

2021-06-30

Completion date

2024-03-15

Last updated

2024-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A

Brief summary

This study is about a factor VIII medicine called Adynovate (TAK-660) used during surgery for people with hemophilia A who have low blood levels of factor VIII. The aims of this study are as follows: * To check for side effects from TAK-660. * To check how well TAK-660 controls bleeding when used routinely during surgery and other invasive procedures such as tooth extractions. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. During the study, participants will receive infusions of TAK-660 during their hospital stay for surgery according to their clinic's standard practice. The study doctors will check for bleeds and side effects from TAK-660 from surgery until discharge.

Interventions

BIOLOGICALPEGylated Recombinant Factor VIII

Polyethylene glycol (PEG)-ylated full-length recombinant FVIII (rFVIII)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Participants with blood coagulation factor VIII (FVIII) deficiency who received this drug during surgery or treatment after the start date of this survey.

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Adverse Reactions Categorized as Inhibitor Development, Shock, or Anaphylaxis	Up to 30 Days	An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. Number of participants with adverse reactions categorized as inhibitor development, shock, or anaphylaxis was reported.
Number of Participants With Serious Adverse Events	Up to 30 Days	A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Number of Participants With Adverse Drug Reaction	Up to 30 Days	An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. Adverse drug reaction refers to AE related to administered drug.
Number of Participants With Serious Adverse Drug Reaction	Up to 30 Days	A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. Adverse drug reaction refers to AE related to administered drug.
Number of Participants With Adverse Events	Up to 30 Days	An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.

Secondary

Measure	Time frame	Description
Postoperative Hemostatic Efficacy of Recombinant FVIII PEGylated Intravenous Infusion 1 Day After Surgery	1 Day post-surgery	The number of surgeries with each rating on hemostatic efficacy was counted and the percentage was reported. Postoperative hemostatic efficacy 1 day after surgery was assessed by following four rating and criteria. Excellent: Postoperative hemostasis achieved with study drug was as good or better than that expected for the type of surgical procedure performed in a nonhemophilic population, Good: Postoperative hemostasis achieved with study drug was probably as good as that expected for the type of surgical procedure performed in a nonhemophilic population, Fair: Postoperative hemostasis with study drug was clearly less than optimal for the type of procedure performed but was maintained without necessitating rescue therapy with study drug or other replacement therapy, None: Participant experienced uncontrolled bleeding that was the result of inadequate therapeutic response despite proper dosing, necessitating rescue therapy with study drug or other replacement therapy.
Postoperative Hemostatic Efficacy of Recombinant FVIII PEGylated Intravenous Infusion at Completion of Perioperative Management	At completion of perioperative management (approximately 30 days after surgery)	Postoperative hemostatic efficacy at completion of perioperative management was assessed by following four rating and criteria. Excellent: Postoperative hemostasis achieved after Day 1 with study drug was as good or better than that expected for the type of surgical procedure performed in a non-hemophilic population, Good: Postoperative hemostasis achieved after Day 1 with study drug was probably as good as that expected for the type of surgical procedure performed in a non-hemophilic population, Fair: Postoperative hemostasis with study drug after Day 1 was clearly less than optimal for the type of procedure performed but was maintained without necessitating rescue therapy with study drug or other replacement therapy, None: Participant experienced uncontrolled bleeding after Day 1 that was the result of inadequate therapeutic response despite proper dosing, necessitating rescue therapy with study drug or other replacement therapy.
Intraoperative Hemostatic Efficacy of Recombinant FVIII PEGylated Intravenous Infusion	Day 1 (date of surgery)	The number of surgeries with each rating on hemostatic efficacy was counted and the percentage was reported. Intraoperative hemostatic efficacy was assessed by following four rating and criteria. Excellent: Intraoperative blood loss was less than or equal to that expected for the type of procedure performed in a non-hemophilic population (≤100%)), Good: Intraoperative blood loss was up to 50% more than expected for the type: of procedure performed in a non-hemophilic population (101-150%), Fair: Intraoperative blood loss was more than 50% of that expected for the type of procedure performed in a non-hemophilic population (\>150%) None: Uncontrolled hemorrhage that was the result of inadequate therapeutic response despite proper dosing, necessitating rescue therapy with study drug or other replacement therapy.

Countries

Japan

Participant flow

Recruitment details

Participants took part in the survey at 10 investigative sites in Japan, from 30 June 2021 to 15 March 2024 .

Pre-assignment details

Participants with coagulation factor VIII (FVIII) deficiency who received Recombinant FVIII PEGylated (ADYNOVATE) for surgery/procedure were enrolled. Participants received ADYNOVATE Intravenous Infusion as part of a routine medical care.

Participants by arm

Arm	Count
Recombinant FVIII PEGylated Intravenous Infusion Participants with coagulation factor VIII (FVIII) deficiency received Recombinant FVIII PEGylated (ADYNOVATE) Intravenous Infusion for surgery/procedure as part of a routine medical care.	15
Total	15

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Protocol Violation	1

Baseline characteristics

Characteristic	Recombinant FVIII PEGylated Intravenous Infusion	—
Age, Continuous	41.4 Years STANDARD_DEVIATION 17.13	—
Race and Ethnicity Not Collected	—	— Participants
Sex: Female, Male Female	1 Participants	—
Sex: Female, Male Male	14 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 15
other Total, other adverse events	1 / 15
serious Total, serious adverse events	1 / 15