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 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT01863758
Eligibility Criteria:
Inclusion Criteria:
* Severe haemophilia A (FVIII:C \< 1%) according to medical history.
* Male patients ≥ 18 years old.
* Previous treatment with a FVIII concentrate (regular prophylaxis with good compliance or on-demand treatment) for at least 150 exposure days (EDs).
* Good documentation regarding dosing and bleeding frequency in the 6 months preceding study start.
* Immunocompetence (CD4+ count \> 200/microliter).
* HIV-negative, if positive, viral load \< 200 particles/microliter or \< 400,000 copies/mL.
* Freely given written informed consent
Exclusion Criteria:
* Any coagulation disorder other than haemophilia A.
* Present or past FVIII inhibitor activity (\> 0.6 Bethesda Unit \[BU\])
* Severe liver or kidney disease.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01863758
Study Brief:
Protocol Section:
NCT01863758