This study investigates the effectiveness and safety of Biostate in children, young adults and adults with von Willebrand Disease, a blood clotting disorder. Patients who completed clinical studies CSLCT-BIO-08-52 or CSLCTBIO-08-54 can be enrolled (extension study).
- Conditions
- Von Willebrand's DiseaseMedDRA 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
- EUCTR2009-017301-11-DE
- Lead Sponsor
- CSL Behring GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 26
1. Completion of Study CSLCT-BIO-08-52 (Assessment of Efficacy and Safety of Biostate in Paediatric Subjects with VWD) or Study CSLCT-BIO-08-54 (Assessment of Efficacy and Safety of Biostate in Adolescent or Adult Subjects with VWD).
2. The subject and/or his/her legal guardian understands the nature of the study, gives written informed consent to participate in the study and is willing to comply with the protocol.
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Early discontinuation of a subject from the main studies CSLCT-BIO-08-52 or CSLCTBIO-08-54.
2. Mental condition rendering the subject (or the subject’s legal guardian) unable to
understand the nature, scope and possible consequences of the study.
3. Any condition that is likely to interfere with evaluation of the investigational medicinal product (IMP) or satisfactory conduct of the study.
4. Are not willing and/or not able to comply with the study requirements.
5. Employee at the study site, or spouse/partner or relative of the Investigator or
Subinvestigators.
6. Female subjects of childbearing potential either not using, or not willing to use, a
medically reliable method of contraception for the entire duration of the study, or not
sexually abstinent for the entire duration of the study, or not surgically sterile.
7. Intention to become pregnant during the course of the study.
8. Pregnancy, or nursing mother.
9. Participation in another clinical study is not allowed during the course of the requested clinical trial period with the exception of the studies CSLCT-BIO-08-52 or CSLCT-BIO-08-54
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