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Описание
Краткое названиеExtension Study of Biostate in Subjects With Von Willebrand Disease
Полное названиеAn 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
СпонсорCSL Behring
Industry
ИсточникCSL Behring
Под контролемBelarus: Ministry of Health
Bulgaria: Bulgarian Drug Agency
Germany: Paul-Ehrlich-Institut
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
Yes
Краткое описаниеThe 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.
СостояниеИдет набор
Дата началаOctober 2010
ФазаPhase 3
Вид исследованияAllocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Набор0
КритерииInclusion 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.
ПолBoth
Минимальный возрастN/A
Максимальный возрастN/A
УсловиеVon Willebrand Disease
Применяемое лечение
BiologicalBiostate
Контакты и расположение
Lviv Study Site
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