EUCTR2004-005157-63-GB进行中（未招募）1 期
An open label, multicenter study to assess the pharmacokinetics, tolerability, and safety of a pediatric formulation of bosentan in children with idiopathic or familial pulmonary arterial hypertension. - FUTURE 1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 33
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
入选标准
- •All patients should start the study drug (bosentan pediatric formulation) at the 2mg/kg b.i.d whether or not they were previously treated with bosentan.
- •Eligible patients must meet all of the following inclusion criteria during the Screening visit:
- •· Signed informed consent by the parents or the legal representatives.
- •· Male or female =2 and < 12 years of age.
- •Females who are menstruating must have a negative serum pregnancy test. A reliable method of contraception must be considered, if appropriate. If using hormonal contraception, an additional alternative reliable method of contraception must be used.
- •- Reliable method of contraception are:
- •Barrier type devices (e.g., female condom, diaphragm, contraceptive sponge) only in combination with a spermicide.
- •Intra-uterine devices.
- •Oral, injectable or implantable contraceptives only in combination with a barrier method.
- •- Hormone-based contraceptives alone, regardless of the route of administration, are not considered as reliable methods of contraception.
- •- Abstention, rhythm method, and contraception by the partner alone are not acceptable methods of contraception.
- •. Idiopathic PAH or familial PAH diagnosed by right heart catheterization
- •(Clinical classification of pulmonary hypertension - Venice 2003).
- •· WHO functional class II or III. (see Appendix 3 of the protocol).
- •· Oxygen saturation (SpO2) = 88% (at rest, on room air).
- •· PAH treatment-naïve patients
- •Patients already treated with either:
- •- Bosentan monotherapy
- •- Intravenous epoprostenol monotherapy
- •- Intravenous or inhaled iloprost monotherapy
- •- Combination of bosentan and intravenous epoprostenol
- •- Combination of bosentan and intravenous or inhaled iloprost.
- •· PAH therapy must have been stable for at least 3 months prior to Screening.
- •· Stable treatment with calcium channel blockers, if any, for at least 3 months prior to Screening.
- •· Patient’s PAH condition must have been stable for at least 3 months prior to Screening.
- •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
- •Patients will not be included in the study if any of the following exclusion criteria are present at the Screening visit:
- •· PAH associated with conditions other than idiopathic or familial PAH.
- •· Non stable patients, e.g., history (in the last 3 months prior to Screening) of recurrent syncope or signs and symptoms of non compensated right heart failure.
- •· Need or plan to wean patients from intravenous epoprostenol, or intravenous or inhaled iloprost.
- •· Body weight < 4 kg.
- •· Systolic blood pressure < 80% the lower limit of normal range, according to age and gender. (See Appendix 1 of the protocol).
- •· AST and/or ALT values > 3 times the upper limit of normal ranges.
- •· Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C. (See Appendix 4 of the protocol).
- •· Hemoglobin and/or hematocrit levels < 75% of the lower limit of normal ranges.
- •· Pregnancy.
- •· Known intolerance or hypersensitivity to bosentan or any of the excipients.
研究者
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