A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A

Baxalta

Status: Active, not recruiting

Conditions: Hemophilia A

Treatments: Biological: ADYNOVI/ADYNOVATE

Study type: Observational

Funder types: Industry

Identifiers

NCT04158934

EUPAS35698 (Registry Identifier)

TAK-660-403

Details and patient eligibility

About

The main aim of this study is to check for long-term side effects from ADYNOVI/ADYNOVATE prophylaxis in participants with haemophilia A when used under standard clinical practice in the real-world clinical setting.

Enrollment: 207 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Signed informed consent obtained from participant and/or legally authorised representative before any study related activities (any procedure related to recording of data according to the protocol).
• Participant at any age with haemophilia A prescribed ADYNOVI/ADYNOVATE prophylaxis.
• Negative factor VIII (FVIII) inhibitor test at study entry.
• Decision to initiate treatment with commercially available ADYNOVI/ADYNOVATE has been made by the participant and/or legally authorised representative and the treating physician before and independently from the decision to include the participant in this study.

Exclusion Criteria

• Previous participation in this study. Participation is defined as signed informed consent.
• Known or suspected hypersensitivity to ADYNOVI/ADYNOVATE or related products.
• Mental incapacity, unwillingness or other barriers precluding adequate understanding or cooperation.

Trial design

207 participants in 1 patient group

Haemophilia A Group

Description:

Participants with haemophilia A in the study will receive ADYNOVI/ADYNOVATE prescribed prophylactically by physicians based on their standard clinical practice and in accordance with the national summary of product characteristics (SmPC).

Treatment:

Biological: ADYNOVI/ADYNOVATE