Исследования / № 01224808
|Краткое название||Extension Study of Biostate in Subjects With Von Willebrand Disease|
|Полное название||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|
|Под контролем||Belarus: Ministry of Health|
Bulgaria: Bulgarian Drug Agency
Mexico: Ministry of Health
Poland: The Central Register of Clinical Trials
Russia: Ministry of Health and Social Development of the Russian Federation
Ukraine: State Pharmacological Center - Ministry of Health
|Краткое описание||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.
|Дата начала||October 2010|
|Вид исследования||Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment|
- 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.
- Early discontinuation of a subject from the main studies CSLCT-BIO-08-52 or
- 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
- 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
- Intention to become pregnant during the course of the study.
- Pregnancy, or nursing mother.
|Условие||Von Willebrand Disease|
|Контакты и расположение|