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

Brief Title

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

Official Title

Adynovate Special Drug Use Result Survey (Perioperative Administration)

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.

Study Type

Observational

Primary Outcome

Number of Participants with Adverse Events

Secondary Outcome

 Intraoperative Hemostatic Efficacy of TAK-660

Condition

Hemophilia A

Intervention

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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Estimated Enrollment

Start Date

June 30, 2021

Completion Date

January 31, 2023

Primary Completion Date

January 31, 2023

Eligibility Criteria

        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

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Study Director, ,

Location Countries

Japan

Location Countries

Japan

Administrative Informations

NCT ID

NCT04941898

Organization ID

TAK-660-5002

Secondary IDs

jRCT2031210173

Responsible Party

Sponsor

Study Sponsor

Takeda

Study Sponsor

Study Director, Study Director, Takeda

Verification Date

February 2023