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

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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