EUCTR2005-001967-70-DE进行中（未招募）不适用
An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 - FUTURE 2
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •·Signed informed consent by the parents or the legal representatives.
- •·Patients who completed the FUTURE 1 study.
- •·Patients who tolerated bosentan pediatric formulation and for whom bosentan is considered beneficial at the end of FUTURE 1.
- •·Male or female >= 2 and < 12 years of age at enrollment in FUTURE 2.
- •Females who are menstruating must have a negative pregnancy test. A reliable method of contraception must be considered, if appropriate.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •·Intolerance to bosentan despite dose reductions.
- •·Any clinically significant laboratory abnormality that precludes continuation of bosentan therapy.
- •·Pregnancy or breast-feeding.
- •·Known hypersensitivity to bosentan or any of the excipients.
- •·Premature and permanent study drug discontinuation during FUTURE 1.
研究者
相似试验
进行中（未招募）
1 期
An open-label, long-term, safety, and tolerability extension study using the pediatric formulation of bosentan in the treatment of children with idiopathic or familial pulmonary arterial hypertension who completed FUTURE 1 - FUTURE 2Idiopathic or familial pulmonary arterial hypertensionEUCTR2005-001967-70-GBActelion Pharmaceuticals Ltd.36
进行中（未招募）
1 期
An open-label, long-term, safety and tolerability study of SAR445088 in participants with cold agglutinin disease previously treated with SAR445088 or never treated with SAR445088Autoimmune haemolytic anaemiaMedDRA version: 20.0Level: PTClassification code: 10073785Term: Autoimmune haemolytic anaemia Class: 100000004851CTIS2023-510210-68-00Bioverativ USA Inc.18
进行中（未招募）
1 期
Open label, long-term safety and tolerability extension study of LCQ908 in subjects with Familial Chylomicronemia Syndrome (FCS).Familial Chylomicronemia Syndrome (FCS) (HLP Type I)MedDRA version: 17.1Level: LLTClassification code 10020607Term: HyperchylomicronemiaSystem Organ Class: 100000004861EUCTR2012-000802-32-DEovartis Pharma Services AG42
招募中
不适用
An open label, long term, safety and tolerability study of patients with cold agglutinin disease previously treated with SAR445088 or never treated with SAR445088CADcold agglutinin disease10003816NL-OMON54300Sanofi BV2
进行中（未招募）
不适用
Open label, long-term safety and tolerability extension study of LCQ908 in subjects with Familial Chylomicronemia Syndrome (FCS).Familial Chylomicronemia Syndrome (FCS) (HLP Type I)MedDRA version: 17.1Level: LLTClassification code 10020607Term: HyperchylomicronemiaSystem Organ Class: 100000004861EUCTR2012-000802-32-GBovartis Pharma Services AG42