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Активно (без набиране) Фаза 3 NCT03424018

An Extension Study to Evaluate the Efficacy and Safety of BMN 111 in Children With Achondroplasia

Фаза 3 – широко изпитване преди одобрение
Заболявания: Achondroplasia

Спонсор: BioMarin Pharmaceutical

Налично на: БГ
Обобщение
The intent and design of this Phase 3 study is to assess BMN 111 as a therapeutic option for the treatment of children with Achondroplasia
Кой може да участва
Inclusion Criteria: * Must have completed Study 111-301 * Female \>= 10 years old or who have begun menses must have a negative pregnancy test at the Baseline Visit and be willing to have additional pregnancy tests during the study * If sexually active, willing to use a highly effective method of contraception while participating in the study * Are willing and able to perform all study procedures * Parent(s) or guardian(s) are willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to performance of any research-related procedure. Also, subjects under the age of majority are willing and able to provide written assent (if required by local regulations or the IRB/IEC) after the nature of the study has been explained and prior to performance of any research-related procedure. Subjects who reach the age of majority in their country while the study is ongoing will be asked to provide their own written consent again upon reaching the legal age of majority. Exclusion Criteria: * Permanently discontinued BMN 111 or placebo prior to completion of the 111-301 study * Have a clinically significant finding or arrhythmia on Baseline ECG that indicates abnormal cardiac function * Evidence of decreased growth velocity (\<1.5 cm/year) as assessed over a period of at least 6 months or of growth plate closure (proximal tibia, distal femur) through bilateral lower extremity X-rays. * Require any investigational agent prior to completion of study period * Current therapy with medications known to alter renal function * Pregnant or breastfeeding or plan to become pregnant during study * Concurrent disease or condition that, in the view of the investigator, would interfere with study participation or safety evaluations, for any reason. * Have a condition or circumstance that, in the view of the investigator, places the subject at high risk for poor treatment compliance or for not completing the study.
Места на провеждане 7
Австралия (1)
The Children's Hospital at Westmead
Westmead , New South Wales
Германия (1)
Otto-von-Gericke Universitaet, Universitaetskinderklinik
Magdeburg
Япония (1)
Osaka University Hospital
Osaka
Испания (1)
Institut Catala de Traumatologica I Medicina de l'Esport
Barcelona
Турция (1)
Acibadem University School of Medicine
Istanbul
Великобритания (1)
Guy's and St. Thomas NHS Foundation Trust Evelina Children's Hospital
London
САЩ (1)
Children's Hospital & Research Center Oakland
Oakland , California
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
6 Years
Здрави доброволци
Не
Начална дата
12.12.2017
Крайна дата
01.06.2031
Регистрационен номер
NCT03424018
Източник
anzctr
Запитване за медицински туризъм

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