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 @ 6:32 PM
Ignite Modification Date:
2025-12-24 @ 6:32 PM
NCT ID:
NCT01562457
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of congenital haemophilia A or B with a FVIII:C (Activated Coagulation Factor VIIa Clotting activity) or FIX:C (Coagulation Factor IX Clotting activity) one stage activity, respectively, at less than 5% of normal (based on medical records) plus/minus inhibitors (a positive inhibitor status defined as 0.6 Bethesda units)
* Non-bleeding state (i.e. no clinical manifestation of active bleed) at the time of administration of trial product
Exclusion Criteria:
* Known or suspected allergy to trial product or any of its components or to related products
* Known clinically relevant coagulation disorders or insufficiencies other than congenital haemophilia A or B
* Platelet count below 50,000 platelets/mcL
* Received any haemostatic treatment (e.g. Feiba) within the last 7 days prior to administration of trial product, except for activated recombinant human factor VII
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
16 Years
Study:
NCT01562457
Study Brief:
Protocol Section:
NCT01562457