EUCTR2010-021825-11-NL进行中（未招募）不适用
An open label, prospective multicenter study to assess the pharmacokinetics, tolerability, safety and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension - FUTURE 3
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 64
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. PAH diagnosis confirmed with RHC:
- •- Idiopathic or heritable PAH, or
- •- Associated PAH persisting after complete repair of a congenital heart defect (PAH has to be persistent for at least 6 months after surgery), or
- •- PAH-CHD (associated with systemic-to-pulmonary shunts, including Eisenmenger syndrome), with PVR > 8 Wood Units and Qp/Qs < 2
- •2. WHO Functional Class I, II or III
- •3. Male or female = 3 months and < 12 years of age (maximum age at randomization is 11.5 years)
- •4. Body weight =3,5 kg
- •5. Peripheral oxygen saturation (SpO2) = 88% (at rest, on room air). (in patients with Eisenmenger syndrome SpO2 = 70%)
- •6. Baseline PAH-therapy (calcium channel blocker, bosentan, intravenous or inhaled prostanoid, oral PDE-5 inhibitor) if present, has to be stable for at least 3 months prior to screening.
- •During the study, all background treatments should remain stable.
- •7. Signed informed consent by the parents or legal representatives
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 64
- •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. PAH etiologies other than listed above
- •2. Non-stable disease status
- •3. Need or plan to wean patient from intravenous epoprostenol or intravenous or inhaled iloprost.
- •4. Systolic blood pressure < 80% of the lower limit of normal range.
- •5. AST and/or ALT values > 1.5 times the upper limit of normal range.
- •6. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C
- •7. Hemoglobin and/or hematocrit levels < 75% of the lower limit of normal range.
- •8. Known intolerance or hypersensitivity to bosentan or any of the excipients of the dispersible Tracleer tablet.
- •9. Treatment with forbidden medication within 2 weeks or at least 5 times the half-life prior to randomization, whichever is the longest:
- •-Glibenclamide (glyburide)
- •-Cyclosporin A
- •-Sirolimus
- •-Tacrolimus
- •-Fluconazole
- •-Rifampicin (rifampin)
- •-Ritonavir
- •-Co-administration of CYP2C9 inhibitors (e.g., amiodarone, voriconazole) and moderate/strong CYP3A4 inhibitors (e.g., amprenavir, erythromycin, ketoconazole, diltiazem, itraconazole)
- •-Endothelin receptor antagonists (ERAs) other than bosentan
- •10. Treatment with another investigational drug within 1 month prior to randomization or planned treatment.
研究者
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