Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:07 AM
Ignite Modification Date:
2025-12-25 @ 1:07 AM
NCT ID:
NCT00947193
Eligibility Criteria:
Inclusion Criteria:
* Ability to provide written informed consent
* Age ≥18 years
* Presence of a nonsense mutation as the sole disease-causing mutation in the FVIII or FIX gene
* At least 20 prior treatments with FVIII or FIX concentrates
* Willingness and ability to comply with scheduled visits, drug administration plan, study restrictions, and study procedures
Exclusion Criteria:
* Known hypersensitivity to any of the ingredients or excipients of the study drug
* Any history of prior anti-FVIII/FIX inhibitors
* Unable or unwilling to forego prophylactic FVIII/FIX concentrate use during the screening and on-study periods (Note: Participants were allowed use of FVIII/FIX concentrates for treatment of bleeding episodes while on study)
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00947193
Study Brief:
Protocol Section:
NCT00947193