Bio Spec Overview
Ignite Creation Date:
2025-12-26 @ 11:14 AM
Last Modification Date:
2025-12-26 @ 11:14 AM
Retention:
SAMPLES_WITH_DNA
Description:
All participants have the option to provide consent to have specimens stored in the ATHN Transcends Biorepository.
Inhibitor titer testing will be performed locally (unless otherwise specified) as per standard of care which is generally expected to coincide with the following:
* Baseline Visit
* Annual Visit
* Product switch
* Suspected inhibitor development
* Confirmatory test for previously elevated result
* Study Exit
* Additional timepoints per any modules
Genetic testing (performed once) will be optional and provided by central labs, as funding allows, across all cohorts.
Anti-drug antibodies testing - For participants receiving non-factor products (e.g., emicizumab) and if testing is clinically appropriate (suspicion of anti-drug antibodies forming), this specimen will be analyzed, as funding allows.
Factor activity testing will be performed locally at the following timepoints:
* Baseline visit
* 6 and 18-month follow-up visits
* Annual visit
* Ad hoc
* Study arm exit
Inhibitor titer testing will be performed locally (unless otherwise specified) as per standard of care which is generally expected to coincide with the following:
* Baseline Visit
* Annual Visit
* Product switch
* Suspected inhibitor development
* Confirmatory test for previously elevated result
* Study Exit
* Additional timepoints per any modules
Genetic testing (performed once) will be optional and provided by central labs, as funding allows, across all cohorts.
Anti-drug antibodies testing - For participants receiving non-factor products (e.g., emicizumab) and if testing is clinically appropriate (suspicion of anti-drug antibodies forming), this specimen will be analyzed, as funding allows.
Factor activity testing will be performed locally at the following timepoints:
* Baseline visit
* 6 and 18-month follow-up visits
* Annual visit
* Ad hoc
* Study arm exit
Section:
All participants have the option to provide consent to have specimens stored in the ATHN Transcends Biorepository.
Inhibitor titer testing will be performed locally (unless otherwise specified) as per standard of care which is generally expected to coincide with the following:
* Baseline Visit
* Annual Visit
* Product switch
* Suspected inhibitor development
* Confirmatory test for previously elevated result
* Study Exit
* Additional timepoints per any modules
Genetic testing (performed once) will be optional and provided by central labs, as funding allows, across all cohorts.
Anti-drug antibodies testing - For participants receiving non-factor products (e.g., emicizumab) and if testing is clinically appropriate (suspicion of anti-drug antibodies forming), this specimen will be analyzed, as funding allows.
Factor activity testing will be performed locally at the following timepoints:
* Baseline visit
* 6 and 18-month follow-up visits
* Annual visit
* Ad hoc
* Study arm exit