Actively Recruiting
Efficacy and Safety of Fanhdi®, a High-purity Von Willebrand Containing FVIII Concentrate, in Pediatric Patients With Von Willebrand Disease
Led by Grifols Therapeutics LLC · Updated on 2024-07-08
8
Participants Needed
4
Research Sites
678 weeks
Total Duration
On this page
Sponsors
G
Grifols Therapeutics LLC
Lead Sponsor
I
Instituto Grifols, S.A.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Multicenter, prospective, non-controlled study in a pediatric cohort (\<6 years-old) with severe (type 2 or 3) hereditary Von Willebrand Disease (VWD).
CONDITIONS
Official Title
Efficacy and Safety of Fanhdi®, a High-purity Von Willebrand Containing FVIII Concentrate, in Pediatric Patients With Von Willebrand Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with severe (type 2 or 3) hereditary von Willebrand disease with VWF:RCo or VWF:Act less than 15-20 IU/dL
- Under 6 years of age
- Signed informed consent form provided by an authorized representative according to local laws and policies
You will not qualify if you...
- Diagnosed with acquired von Willebrand disease
- Active bleeding at the time of first infusion or within 10 days before infusion
- Treated with DDAVP or another factor VIII containing von Willebrand factor concentrate within 5 days before Fanhdi infusion (3 days for type 3 VWD)
- Positive for anti-VWF or anti-FVIII antibodies (≥0.5 Bethesda Units) currently or historically
- Known allergies or intolerance to substances in Fanhdi
- History of anaphylactic reaction to blood or blood components
- Severe platelet dysfunction due to drug use or congenital/acquired platelet disorders
- Known previous infection or symptoms of hepatitis A, B, C, or HIV
- Anemia with hemoglobin less than 11 g/dL
- Uncontrolled metabolic diseases like diabetes mellitus
- Participation in another clinical trial within 30 days or received investigational product within 3 months prior to screening
- Expected treatment with other factor VIII or von Willebrand factor products besides Fanhdi during the study
- Potential compliance problems as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Hospital Sant Joan de Déu Barcelona
Esplugues de Llobregat, Barcelona, Spain, 08950
Actively Recruiting
2
Hospital Universitario La Paz
Madrid, Spain
Actively Recruiting
3
Hospital Universitario Virgen del Rocío
Seville, Spain, 41013
Actively Recruiting
4
Hospital Universitario Miguel Servet
Zaragoza, Spain
Actively Recruiting
Research Team
N
Núria Ribó
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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