Evaluation of the Pharmacokinetic Profile, Clinical Efficacy and Safety of the Von Willebrand Factor Contained in FANHDI® (Double-inactivated Human Anti-hemophilic Factor) in Pediatric Subjects With Severe Von Willebrand Disease
Who is this study for? Pediatric patients age 2 months to 6 years with Von Willebrand disease
What treatments are being studied? Plasma-derived FVIII/VWF concentrate
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 2 months
Maximum Age: 6
Healthy Volunteers: f
View:
• Subjects diagnosed with severe (type 2 or 3) hereditary VWD (VWF:RCo\<15-20 IU/dL), or VWF:Act\<15-20 IU/dL.
• Subjects under 6 years of age.
• Signed informed consent form (ICF) provided by an authorized representative on behalf of the subject in accordance with local law and institutional policy.
Locations
Other Locations
Spain
Hospital Sant Joan de Déu Barcelona
RECRUITING
Esplugues De Llobregat
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Virgen del Rocío
RECRUITING
Seville
Hospital Universitario Miguel Servet
RECRUITING
Zaragoza
Contact Information
Primary
Núria Ribó
nuria.ribo@grifols.com
Time Frame
Start Date: 2013-12
Estimated Completion Date: 2026-12
Participants
Target number of participants: 8
Treatments
Experimental: plasma-derived FVIII/VWF concentrate
Pharmacokinetic single dose study with Fanhdi (high-purity Von Willebrand containing FVIII concentrate)
Authors
Rosario Pérez
Related Therapeutic Areas
Sponsors
Leads: Grifols Therapeutics LLC
Collaborators: Instituto Grifols, S.A.