NCT02472665 Efficacy and Safety of Fanhdi®, a High-purity Von Willebrand Containing FVIII Concentrate, in Pediatric Patients With Von Willebrand Disease
| NCT ID | NCT02472665 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Grifols Therapeutics LLC |
| Condition | Von Willebrand Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 8 participants |
| Start Date | 2013-12 |
| Primary Completion | 2025-04 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
Multicenter, prospective, non-controlled study in a pediatric cohort (\<6 years-old) with severe (type 2 or 3) hereditary Von Willebrand Disease (VWD).
Eligibility Criteria
Inclusion Criteria: 1. Subjects diagnosed with severe (type 2 or 3) hereditary VWD (VWF:RCo\<15-20 IU/dL), or VWF:Act\<15-20 IU/dL. 2. Subjects under 6 years of age. 3. Signed informed consent form (ICF) provided by an authorized representative on behalf of the subject in accordance with local law and institutional policy. Exclusion Criteria: 1. Subjects diagnosed with acquired VWD. 2. Subjects with active bleeding at the time of the first infusion or within 10 days prior to the infusion. 3. Subjects who have been treated with DDAVP or another FVIII containing VWF concentrate during the 5 days prior to the infusion of the Fanhdi. This treatment-free period may be reduced to 3 days for subjects with type 3 VWD. 4. Subject who are positive for anti-VWF or anti-FVIII antibodies (≥0.5 Bethesda Units) or has been positive in the history of their disease. 5. Subjects with a known allergies/intolerance to any substance contained in Fanhdi. 6. Subjects with a known history of anaphylactic reac