Post Marketing Surveillance Study for ADYNOVATE in South Korea

Takeda

Status: Completed

Conditions: Hemophilia A

Treatments: Biological: ADYNOVATE

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT03824522

261603

Details and patient eligibility

About

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.

Enrollment: 341 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Participants with a diagnosis of hemophilia A who will be newly prescribed with ADYNOVATE or already have been prescribed ADYNOVATE according to the study physician's judgment shall be included in this study if:

• The participant or legally authorized representative has given written informed consent to participate in the study.
• The participant is indicated for treatment according to the ADYNOVATE South Korea prescribing information (PI).

Exclusion Criteria

Participants should be excluded from this study if:

• The participant or legally authorized representative does not wish to participate in the study.
• Any of the contraindications included in the PI for ADYNOVATE apply.
• Participant is enrolled in an interventional trial using an investigational product other than ADYNOVATE.

Trial design

341 participants in 1 patient group

All Study Participants

Description:

Participants who are newly prescribed with Adynovate and participants previously treated with Adynovate will be treated with ADYNOVATE for hemophilia A at the time of enrollment according to a regimen determined by the study site treating physician.

Treatment:

Biological: ADYNOVATE