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:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT02528968
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Severe haemophilia A (FVIII:C \< 1IU/dL)
* Prescribed regular prophylactic treatment (≥ 2 infusions/week) with Advate® for ≥ 6 months at the time of screening
* Able to give informed consent and willing to participate in this study
Exclusion Criteria:
* Age \<18 years
* Non-severe haemophilia A (FVIII:C 1-40IU/dL)
* Weight \>120kg
* Treatment with any other FVIII concentrate (recombinant or plasma-derived) during the study period or 6 months prior to screening.
* Receiving on-demand or \<6 months of prescribed prophylaxis with Advate®
* Current FVIII inhibitor (\> 0.6BU/mL)
* Current immune tolerance induction
* Not able to give informed consent (incapacitated or vulnerable adults)
* Patients with a life expectancy of less than one year
* Already had personalized PK prediction using the myPKFiT®
* Any inclusion criteria not met
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02528968
Study Brief:
Protocol Section:
NCT02528968