Исследования / № 01224808
| Описание | |
|---|---|
| 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 |
| Спонсор | CSL Behring Industry |
| Источник | CSL Behring |
| Под контролем | Belarus: 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 |
| 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. |
| Состояние | Идет набор |
| Дата начала | October 2010 |
| Фаза | Phase 3 |
| Вид исследования | Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Набор | 0 |
| Критерии | 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. |
| Пол | Both |
| Минимальный возраст | N/A |
| Максимальный возраст | N/A |
| Условие | Von Willebrand Disease |
| Применяемое лечение | |
|---|---|
| Biological | Biostate |
| Контакты и расположение | |
|---|---|
| Lviv | Study Site |
