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

Adynovate Special Drug Use Result Survey (Perioperative Administration)

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.

Study Overview

• Status: Completed
• Conditions: Hemophilia A
• Intervention / Treatment: Biological: PEGylated Recombinant Factor VIII

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Takeda Selected Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TAK-660 15-50 international units per kilograms (IU/kg); Participants will receive TAK-660 15-50 IU/kg slow intravenous injection every 8- 24 hours until the bleeding is resolved or wound healing.	Biological: PEGylated Recombinant Factor VIII; Polyethylene glycol (PEG)-ylated full-length recombinant FVIII (rFVIII); Other Names: ADYNOVATE; TAK-660; BAX855

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events	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.	Up to 30 days
Number of Participants with Serious Adverse Events	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.	Up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Hemostatic Efficacy of TAK-660	Intraoperative hemostatic efficacy will be 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.	Day 1 (date of surgery)
Postoperative Hemostatic Efficacy of TAK-660 1 Day after Surgery	Postoperative hemostatic efficacy 1 day after surgery will be 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.	1 Day post-surgery
Postoperative Hemostatic Efficacy of TAK-660 at Completion of Perioperative Management	Postoperative hemostatic efficacy at completion of perioperative management will be 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.	At completion of perioperative management (approximately 30 days after surgery)

Collaborators and Investigators

• Sponsor: Takeda
• Investigators: Study Director: Study Director, Takeda

Publications and helpful links

Helpful Links

• To obtain more information on the study, click here/on this link

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Actual): March 15, 2024
• Study Completion (Actual): March 15, 2024

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: June 25, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Blood Coagulation Disorders; Hemophilia A; Coagulants; Factor VIII; BAX 855
• Other Study ID Numbers: TAK-660-5002; jRCT2031210173 (Registry Identifier: jRCT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified individual participant data from this particular study will not be shared as there is a reasonable likelihood that individual patients could be reidentified (due to the limited number of study participants/study sites).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No