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 @ 11:16 PM
Ignite Modification Date:
2025-12-24 @ 11:16 PM
NCT ID:
NCT01575756
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 12 years.
* Documented congenital fibrinogen deficiency (afibrinogenemia).
Exclusion Criteria:
* Life expectancy \> 6 month.
* Bleeding disorder other than congenital fibrinogen deficiency.
* Presence or history of hypersensitivity to study medication.
* Presence or history of deep vein thrombosis or pulmonary embolism within 1 year prior to enrollment.
* Presence or history of arterial thrombosis with 1 year prior to enrollment.
* Hypersensitivity to human plasma products.
* Acute bleeding.
* Pregnant or currently breast-feeding women.
* Suspicion of an anti-fibrinogen inhibitor as indicated by previous in vivo recovery (if available).
* Blood or plasma donation in the 3 months prior to enrollment.
* Human immunodeficiency virus (HIV) positive with a viral load \> 200 particles/µl or \> 400000 copies/mL.
* End-stage liver disease.
* History of oesophageal varicose bleeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT01575756
Study Brief:
Protocol Section:
NCT01575756