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 @ 3:50 PM
Ignite Modification Date:
2025-12-24 @ 3:50 PM
NCT ID:
NCT00922792
Eligibility Criteria:
Inclusion Criteria:
* Haemophilia A or B
* Bodyweight max 100 kg
* Body Mass Index (BMI) max 30 kg/m2
* Adequate venous access
Exclusion Criteria:
* Known or suspected allergy to trial product(s) or related products (including NovoSeven®)
* The receipt of any investigational product within 30 days prior to enrolment in this trial
* Receipt of Immune Tolerance Induction (ITI) within the last 1 month prior to participation in this trial
* The receipt of any haemostatic treatment for control of a bleeding episode within the last 5 days prior to administration of trial product
* Receipt of FVIII or FIX replacement therapy within 48 hours prior to trial product administration
* Known pseudo tumours
* Congenital or acquired coagulation disorders other than haemophilia A or B
* Any major and/or orthopaedic surgery within one month prior to trial start
* Advanced atherosclerotic disease (defined as known history of ischemic heart disease, ischemic stroke, etc.)
* Clinical signs of renal dysfunction
* Use of platelet inhibitors, including NSAIDs, one week prior to administration of trial drug
* Use of non-prescribed opiate substances
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00922792
Study Brief:
Protocol Section:
NCT00922792