NCT04941898

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

Adynovate Special Drug Use Result Survey (Perioperative Administration)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 16 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Hemophilia A

Interventions

Type	Name	Description
BIOLOGICAL	PEGylated Recombinant Factor VIII	Polyethylene glycol (PEG)-ylated full-length recombinant FVIII (rFVIII)

Timeline

• Start date: 2021-06-30
• Primary completion: 2024-03-15
• Completion: 2024-03-15
• First posted: 2021-06-28
• Last updated: 2024-11-15
• Results posted: 2024-11-15

Locations

1 site across 1 country: Japan