EUCTR2011-004612-31-NL进行中（未招募）1 期
A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension - FUTURE 6
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 105
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
- •1. Signed informed consent by the parents / legal representatives prior to any study-mandated procedure.
- •2. Patients who:
- •- were treated for 12 weeks in FUTURE 5
- •- discontinued FUTURE 5 due to PAH-progression.
- •And who performed the Visit 5 assessments of FUTURE 5 according to the FUTURE 5 protocol.
- •3. Patients who did not prematurely discontinue the study drug due to AEs in FUTURE 5.
- •4. Females of childbearing potential must have a negative pre treatment serum pregnancy test and must use reliable methods of contraception during the whole treatment period and for 1 month after study drug discontinuation.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 105
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Known intolerance or hypersensitivity to bosentan or any of the excipients of the bosentan dispersible tablet.
- •2. Pregnancy or breastfeeding.
- •3. Any AST and/or ALT values > 3 times the upper limit of normal range (ULN) until Visit 5 of FUTURE 5 (inclusive).
- •4. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C until Visit 5 of FUTURE 5 (inclusive).
- •5. Any condition that prevents compliance with FUTURE 6 protocol or adherence to therapy.
研究者
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