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 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT00837356
Eligibility Criteria:
Inclusion Criteria:
* Severe haemophilia A (FVIII level less than or equal to 1%)
* Treatment history of more than 150 exposure days with recombinant or plasma-derived FVIII replacement products
* HIV or HCV negative, or if positive the patient is on a stable antiviral regimen at the time of the enrolment in the trial
Exclusion Criteria:
* Presence of any bleeding disorder in addition to haemophilia A
* Inhibitor titre greater than or equal to 0.6 Bethesda Units (BU) at screening and past history of inhibitor
* Abnormal renal function tests
* Known hypersensitivity to Advate®
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
12 Years
Maximum Age:
55 Years
Study:
NCT00837356
Study Brief:
Protocol Section:
NCT00837356