Von Willebrand Disease

Extension Study of Biostate in Subjects With Von Willebrand Disease

NCT01224808 | PHASE 3 | 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.

6 Sites

20 Participants

Recruiting

2 Years to 65 Years

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SUBMIT

Study Site

Sofia,Bulgaria

Study Site

Bremen,Germany

Study Site

Warsaw,Poland

Study Site

Wroclaw,Poland

Study Site

Barnaul,Russian Federation

Study Site

Lviv,Ukraine

Study Eligibility Criteria

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.

Additional Studies

Additional studies can be found at ClinicalTrials.gov