A Prospective, Multicenter, Open-label Extension of FUTURE 3 to Assess the Safety, Tolerability and Efficacy of the Pediatric Formulation of Bosentan Two Versus Three Times a Day in Children With Pulmonary Arterial Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 36
- 主要终点
- Treatment Emergent Adverse Events (AEs) up to 7 Days After Permanent Study Drug Discontinuation
研究概览
简要总结
The objectives of the FUTURE 3 Study Extension are to evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with Pulmonary Arterial Hypertension (PAH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who completed the FUTURE 3 core study (AC-052-373) or prematurely discontinued due to PAH-progression, if bosentan was not permanently discontinued
- •Patients who tolerated bosentan pediatric formulation and for whom bosentan is considered beneficial at the end of the FUTURE 3 core study (AC-052-373)
- •Signed informed consent by the parents or the legal representatives prior to any study-mandated procedure.
排除标准
- •Known intolerance or hypersensitivity to bosentan or any of the excipients of the dispersible bosentan tablet
- •Any clinically significant laboratory abnormality that precludes continuation of bosentan therapy
- •AST and/or ALT values > 3 times the upper limit of normal range (ULN)
- •Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
- •Premature and permanent study drug discontinuation during the FUTURE 3 core study (AC-052-373)
- •Any major violation of the FUTURE 3 core study (AC-052-373) protocol.
研究组 & 干预措施
bosentan 2mg/kg b.i.d.
Patients who received 2 mg/kg bosentan twcie daily (b.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study
干预措施: Bosentan (Drug)
bosentan 2mg/kg t.i.d.
Patients who received 2 mg/kg bosentan 3 times a day (t.i.d.) during the FUTURE 3 core study and continued with the same dose regimen during the extension study
干预措施: Bosentan (Drug)
结局指标
主要结局
Treatment Emergent Adverse Events (AEs) up to 7 Days After Permanent Study Drug Discontinuation
时间窗: Up to 62 weeks in average
This is the total number of subjects with at least one adverse event (serious or not serious) whether or not causally related to the study drug and presented cumulatively in the FUTURE 3 and FUTURE 3 Extension study. NOTE: FUTURE 3 extension study was exploratory and no primary efficacy and safety endpoints were defined in the protocol. So, this safety outcome measure was selected and reported as primary endpoint here.
次要结局
未报告次要终点