NCT01224808CompletedPhase 3
An Open-Label, Multi-Centre Extension Study to Assess the Efficacy and Safety of Biostate® in Paediatric, Adolescent, and Adult Subjects With Von Willebrand Disease Who Completed Clinical Studies CSLCT-BIO-08-52 or CSLCTBIO-08-54
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- CSL Behring
- Enrollment
- 20
- Locations
- 6
- Primary Endpoint
- Haemostatic efficacy
Study Overview
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 Willebrand Factor (VWF) and/or Factor VIII (FVIII) levels. The long-term efficacy and safety of a VWF/FVIII concentrate, Biostate, will be investigated in children, adolescents, and adults with VWD in whom treatment with a VWF product is required for prophylactic therapy, haemostatic control during surgery, or control of a non-surgical, spontaneous, or traumatic bleeding event.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •Early discontinuation of a subject from the main studies CSLCT-BIO-08-52 or CSLCT-BIO-08-
- •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.
Outcomes
Primary Outcomes
Haemostatic efficacy
Time Frame: Up to 32 months
Secondary Outcomes
- Development of FVIII inhibitors(Up to 32 months)
- Frequency of Adverse events (AEs) per subject(32 months)
- Development of VWF inhibitors(Up to 32 months)
- Severity of AEs per subject(32 months)
- Causality of AEs per subject(32 months)
- Causality of AEs per infusion(32 months)
- Severity of AEs per infusion(32 months)
- Frequency of Adverse events (AEs) per infusion(32 months)
Investigators
Study Sites (6)
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