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.
Trial at a glance
What medical condition is being studied? Hemophilia A
What is the trial testing? PEGylated Recombinant Factor VIII
Are placebos part of the trial? No
How many participants are being enrolled? 15
When is the trial being conducted? -
Accepts Healthy Volunteers?
Trial Details / Participation Requirements
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Trial Type: Observational
Trial Arms/Groups or Cohorts:
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.
Intervention: PEGylated Recombinant Factor VIII
Primary Outcome Measure(s):
Number of Participants with Adverse Events [Time Frame: Up to 30 days]
Number of Participants with Serious Adverse Events [Time Frame: Up to 30 days]
Secondary Outcome Measure(s):
Intraoperative Hemostatic Efficacy of TAK-660 [Time Frame: Day 1 (date of surgery)]
Postoperative Hemostatic Efficacy of TAK-660 1 Day after Surgery [Time Frame: 1 Day post-surgery]
Postoperative Hemostatic Efficacy of TAK-660 at Completion of Perioperative Management [Time Frame: At completion of perioperative management (approximately 30 days after surgery)]
- Participants with blood coagulation factor VIII (FVIII) deficiency who received this
drug during surgery or treatment after the start date of this survey.
Takeda Selected Site
2,960 miles (4,763 km) awayfrom Новосибирск, Новосибирская область
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Trial Protocol ID: TAK-660-5002
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