International clinical study to investigate the efficacy and safety of Wiloctin in patients with inherited von willebrand disease (vWD)
- Conditions
- von Willebrand Jürgends syndrom in children under 6 years of age
- Registration Number
- EUCTR2006-002857-54-DE
- Lead Sponsor
- Octapharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
Patients with defined inherited vWD of any type, not responding to DDAVP treatment, who need treatment with plasma derived vWF may be included. Age > 6 and < 85 years. Patients who did not receive other plasma derived or blood products 72 hours before treatment with WILOCTIN, who did not receive DDAVP 15 days or acetylsalicylic acid 7 days before treatment. Patients without severe liver or kidney disease.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Administration of other plasma derived or blood product 72 hours before treatment.
Administration of DDAVP 15 days before treatment.
Administration of acetylsalicylic acid 7 days before treatment.
Known history of intolerance versus plasma derived or blood products.
Symptomatic infection.
Severe liver or kidney disease (ALAT 5x > normal value, creatinine > 120 µmol/l).
Participation in another clinical study currently or during the past four weeks.
Pregnancy or lactating women.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method