NCT05768386
A Long-Term Follow-Up Study in Severe Hemophilia A Subjects Who Received BMN 270 in a Prior BioMarin Clinical Trial (270-401)
Enrolling by Invitation
Not specifiedAges 18+ObservationalBioMarin Pharmaceutical
~172 participants
Updated 2026-01-12 on ClinicalTrials.gov
At a glance
Recruiting sites
0 of 41 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate the long-term safety of BMN 270
Measured over Duration of study (10 years)
Conditions
Where it's being run
41 sites across 27 statesUnited Kingdom8
California5
Michigan2
São Paulo2
France2
Colorado1
Florida1
Kentucky1
Study leadership
- Medical Director, MD · STUDY_DIRECTOR · BioMarin Pharmaceutical
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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Eligibility criteria
Inclusion
Participants must have completed their primary treatment study or be currently enrolled in the primary treatment study at the time of closure by the Sponsor. Participants may enroll in 270-401 even if they have restarted FVIII prophylaxis or other hemophilia A treatment.
Subjects must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. If the subject is unable to provide consent, a legally authorized representative may provide written informed consent.
Exclusion
Participants who do not directly enroll in 270-401 at the time of the study completion visit in their primary treatment study should enroll in 270-401 within 4 months of the date of that study completion visit. If a participant wishes to enroll in 270-401 after 4 months, they must receive prior approval from the Medical Monitor.
Participants must be overtly healthy and not have any condition that, in the opinion of the Investigator or Medical Monitor, would prevent the participant from fully complying with the requirements of the study and/or would impact or interfere with evaluation and interpretation of the study data (including, if applicable, advanced HIV disease).
Where applicable, per country regulation, the participant must not currently be committed to an institution by virtue of an order issued either by judicial or administrative authorities.
What this trial measures
- Evaluate the long-term safety of BMN 270Duration of study (10 years)
Occurrence of adverse drug reactions, serious adverse events, and events of special interest.