A Study of TAK-660 in surgical procedures for people with hemophilia A

JRCT ID: jRCT2031210173

Registered date:29/06/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hemophilia A
• Date of first enrollment: 30/06/2021
• Target sample size: 17
• Study type: Observational

Outcome(s)

Primary Outcome

1.Number of Participants with Adverse Events
Timeframe: 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.

2.Number of Participants with Serious Adverse Events
Timeframe: 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.

Secondary Outcome

1.Intraoperative Hemostatic Efficacy of TAK-660
Timeframe: Day 1 (date of surgery)
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.

2.Postoperative Hemostatic Efficacy of TAK-660 1 Day after Surgery
Timeframe: 1 Day post-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.

3.Postoperative Hemostatic Efficacy of TAK-660 at Completion of Perioperative Management
Timeframe: At completion of perioperative management (approximately 30 days after surgery)
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.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Participants with blood coagulation factor VIII (FVIII) deficiency who received this drug during surgery or treatment after the start date of this survey.
• Exclude criteria: None

Related Information

• Primary Sponsor: Contact for Clinical Trial Information
• Secondary ID(s): NCT04941898