Status:
COMPLETED
Extension Study of Biostate in Subjects With Von Willebrand Disease
Lead Sponsor:
CSL Behring
Conditions:
Von Willebrand Disease
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
The aim of the Von Willebrand Disease (VWD) therapy is to treat and prevent bleeding episodes due to abnormal platelet adhesion and abnormal blood coagulation as a result of low or abnormal Von Willeb...
Eligibility Criteria
Inclusion
- Have completed Study CSLCT-BIO-08-52 (Assessment of Efficacy and Safety of Biostate in Paediatric Subjects with Von Willebrand Disease) or Study CSLCT-BIO-08-54 (Assessment of Efficacy and Safety of Biostate in Adolescent or Adult Subjects with Von Willebrand Disease).
- The subject and/or his/her legal guardian understand(s) the nature of the study and has/have given written informed consent to participate in the study and is/are willing to comply with the protocol.
Exclusion
- Early discontinuation of a subject from the main studies CSLCT-BIO-08-52 or CSLCT-BIO-08-54.
- Mental condition rendering the subject (or the subject's legal guardian) unable to understand the nature, scope and possible consequences of the study.
- Any condition that is likely to interfere with evaluation of the IMP or satisfactory conduct of the study.
- Are not willing and/or not able to comply with the study requirements.
- Employee at the study site, or spouse/partner or relative of the Investigator or Subinvestigators.
- 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.
- Intention to become pregnant during the course of the study.
- Pregnancy, or nursing mother.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01224808
Start Date
October 1 2010
End Date
March 1 2014
Last Update
October 3 2017
Active Locations (6)
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1
Study Site
Sofia, Bulgaria
2
Study Site
Bremen, Germany
3
Study Site
Warsaw, Poland
4
Study Site
Wroclaw, Poland