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

Recruiting in Palo Alto (17 mi)

+38 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Baxalta now part of Shire

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility 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.

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Treatment Details

Interventions

ADYNOVI/ADYNOVATE (Coagulation Factor VIII Replacement)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Haemophilia A GroupExperimental Treatment1 Intervention

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).