This study in an open label study that is conducted in many centers around the world to investigate whether Wilate is safe and works in patients that need surgery and have von Willebrand disease.
- Conditions
- Surgery in Inherited Von Willebrand Disease (VWD)MedDRA version: 14.1Level: PTClassification code 10047715Term: Von Willebrand's diseaseSystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2010-021162-30-BG
- Lead Sponsor
- Octapharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 41
1. Male and female subjects who are at least 6 years of age.
2.Diagnosed with congenital VWD (any type) where VWF:RCo is below 40% at screening or the subject has a diagnosis of Type 1, 2 or 3 VWD and a history of VWF:RCo below 40% documented in their medical notes at enrolment.
3.Require therapy with a VWF product to treat any potential surgical procedure.
4. Negative for anti-human immunodeficiency virus (HIV); if positive, viral load <200 particles/µL or <400,000 copies/mL and CD4+ count > 200/µL.
5. The subject and/or their legally acceptable representative understands the nature of the study, gives written informed consent to participate in the study and is willing and able to comply with the protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range: 3
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 21
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14
1. Known coagulation disorder other than congenital VWD.
2. Any VWF containing product administered within 3 days prior to the screening visit.
3. Any subject where it is planned to infuse the investigational product via continuous infusion.
4. Have a known history of, or are suspected to have VWF or FVIII inhibitors.
5. Emergency surgery or any surgery with a degree of urgency not permitting completion of baseline assessment required by the study protocol.
6. Suffering an acute or chronic medical condition, other than VWD, which may in the opinion of the Investigator affect the conduct of the study.
7. Subjects with active hepatic disease (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] levels >5 times the upper limit of normal)8. Have a known or suspected hypersensitivity or previous evidence of severe side effects to Wilate® or other VWF/FVIII concentrates.
9. Subjects receiving immune-modulating drugs (other than anti-retroviral chemotherapy) such as alpha-interferon, prednisone (equivalent to >10 mg/day), or similar drugs at study start.
10. Pregnant women within the first 20 weeks of gestation.
11. Subjects having evidence or a history (within the previous 12 months) of abuse of any drug substance, licit or illicit.
12. Participation in another interventional clinical study currently or during the past 4 weeks.
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