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

Takeda

Status: Completed

Conditions: Hemophilia A

Treatments: Biological: PEGylated Recombinant Factor VIII

Study type: Observational

Funder types: Industry

Identifiers

NCT04941898

jRCT2031210173 (Registry Identifier)

TAK-660-5002

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

17 participants in 1 patient group

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.

Treatment:

Biological: PEGylated Recombinant Factor VIII