BridgeMD
A study to investigate long-term follow-up in subjects who received BMN 270 in a prior BioMarin Clinical Trial with hemophilia A
EU CTIS ID: 2023-507749-27-00
What this study is testing
Evaluate the long-term safety of BMN 270
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants must have completed the End of Study Visit in their primary treatment study (Study 270-201, 270-203, 270-205, 270-301, 270-302, or 270-303) or be currently enrolled in one of these studies and have completed a minimum of 24 months of post-infusion follow-up in that 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.
- Participants must be capable of giving signed informed consent as described in Appendix 10.1.3 of the protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
You likely can't join if
- 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, critical data (in particular FVIII activity, bleeding episodes, FVIII use, AEs, SAEs, and the use of hemophilia medications) must be available from the extended duration between studies, and, in the opinion of the Investigator or Medical Monitor, any missing data would not impact or interfere with evaluation and interpretation of the study.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
- Brazil
- Taiwan
- United Kingdom
- Australia
- United States
- Korea, Republic of
- Israel
- South Africa
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turkey; Brazil; Taiwan; United Kingdom; Australia; United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.