Active — Not RecruitingNot Applicable

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

United States, Bulgaria, Croatia207 participantsStarted 2020-07-09

Plain-language summary

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.

Who can participate

SexALL

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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.

What they're measuring

Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)

Timeframe: Throughout the study period (approximately up to 10 years)

Number of Participants With Adverse Events of Special Interest (AESI)

Timeframe: Throughout the study period (approximately up to 10 years)

Number of Participants With Adverse Events (AE) Related to Impaired Renal Function

Timeframe: Throughout the study period (approximately up to 10 years)

Number of Participants With Adverse Events (AE) Related to Impaired Hepatic Function

Timeframe: Throughout the study period (approximately up to 10 years)

Number of Participants With Adverse Events (AE) Related to Impaired Neurologic Function

Timeframe: Throughout the study period (approximately up to 10 years)

Trial details

NCT IDNCT04158934

SponsorBaxalta now part of Shire

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2030-02-28

View on ClinicalTrials.gov More Hemophilia A trials