Von Willebrand Disease Clinical Trial
Official title:
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
Verified date | October 2017 |
Source | CSL Behring |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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-08-54. - 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. |
Country | Name | City | State |
---|---|---|---|
Bulgaria | Study Site | Sofia | |
Germany | Study Site | Bremen | |
Poland | Study Site | Warsaw | |
Poland | Study Site | Wroclaw | |
Russian Federation | Study Site | Barnaul | |
Ukraine | Study Site | Lviv |
Lead Sponsor | Collaborator |
---|---|
CSL Behring |
Bulgaria, Germany, Poland, Russian Federation, Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Haemostatic efficacy | Up to 32 months | ||
Secondary | Development of FVIII inhibitors | Up to 32 months | ||
Secondary | Development of VWF inhibitors | Up to 32 months | ||
Secondary | Frequency of Adverse events (AEs) per subject | 32 months | ||
Secondary | Severity of AEs per subject | 32 months | ||
Secondary | Severity of AEs per infusion | 32 months | ||
Secondary | Causality of AEs per subject | 32 months | ||
Secondary | Causality of AEs per infusion | 32 months | ||
Secondary | Frequency of Adverse events (AEs) per infusion | 32 months |
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