NCT03824522

Post Marketing Surveillance Study for ADYNOVATE in South Korea

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 341 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The main aim of this study is to check for side effects and medical problems in participants with hemophilia A who are receiving ADYNOVATE in routine clinical practice. Also, it will be checked how effective ADYNOVATE is at stopping a bleed, at preventing bleeding episodes when used routinely for prevention and at controlling hemophilia-related bleeding during surgeries. Participants with hemophilia A who will be newly prescribed with ADYNOVATE treatment or have already been taking ADYNOVATE treatment according to the physician's decision will be included in this study. Participants will visit the study clinic as a part of their routine clinical practice and will be contacted by phone calls/home visits by home care workers for collection of treatment related data during the 6-month observation period.

Conditions

• Hemophilia A

Interventions

Type	Name	Description
BIOLOGICAL	ADYNOVATE	Pegylated recombinant human factor VIII

Timeline

• Start date: 2019-02-25
• Primary completion: 2024-01-05
• Completion: 2024-01-05
• First posted: 2019-01-31
• Last updated: 2024-02-26

Locations

8 sites across 1 country: South Korea