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.
Number of Participants with Adverse Events
Intraoperative Hemostatic Efficacy of TAK-660
PEGylated Recombinant Factor VIII
Study Arms / Comparison Groups
TAK-660 15-50 international units per kilograms (IU/kg)
Description: Participants will receive TAK-660 15-50 IU/kg slow intravenous injection every 8- 24 hours until the bleeding is resolved or wound healing.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
June 30, 2021
January 31, 2023
Primary Completion Date
January 31, 2023
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
N/A - N/A
Accepts Healthy Volunteers
Study Director, ,
Study Director, Study Director, Takeda