An Extension of AC-055-310, a Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the French, Italian and Spanish Versions of the PAH-SYMPACT™
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 32
- 主要终点
- To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment in the AC-055-310 study.
研究概览
简要总结
Prospective, multi-center, open-label, single-arm, Phase 3b extension study of macitentan in patients with PAH.
To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment in the AC-055-310 study.
详细描述
To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment in the AC-055-310 study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent prior to any study-mandated procedure.
- •Patients with PAH who completed the ORCHESTRA study (AC-055-310) as scheduled
- •Women of childbearing potential (as defined below) must:
- •Have a negative serum pregnancy test at Visit 1 (i.e., Visit 4 of study AC 055 310) and agree to perform monthly serum pregnancy tests.
- •Agree to use two reliable methods of contraception in parallel, from Visit 1 until 1 month after study drug discontinuation (see details below).
- •A female is considered to have childbearing potential unless she meets at least one of the following criteria:
- •Previous bilateral salpingo and/or oophorectomy, or hysterectomy.
- •Premature ovarian failure confirmed by a specialist.
- •Pre-pubescence, XY genotype, Turner syndrome, uterine agenesis.
- •Postmenopausal, defined as 12 consecutive months with no menses without an alternative medical cause.
- •Of the two contraceptive methods that must be used, one must be from Group 1, and one must be from Group 2, defined as follows:
- •Group 1: Oral, implantable, transdermal or injectable hormonal contraceptives, intrauterine devices, female sterilization (tubal ligation or non-surgical sterilization, e.g., permanent contraception with Essure procedure), or partner's sterilization (vasectomy). If a hormonal contraceptive is chosen from this group, it must be taken for at least one month prior to enrollment. Alternatively, if the Essure procedure is chosen as a contraceptive method, a hysterosalpingogram must have been performed to confirm correct location of the microinserts and tubal occlusion (as per manufacturer's recommendations).
- •Group 2: Female or male condoms, diaphragm or cervical cap, any of them in combination with a spermicide.
- •Sexual abstinence, rhythm methods, or contraception by the partner alone are not considered as acceptable methods of contraception for this study.
排除标准
- •Patients who prematurely discontinued study drug in study AC-055-
- •Females who are lactating or pregnant (positive Visit 1 pregnancy test) or plan to become pregnant during the study.
- •AST and/or ALT more than 3 X ULN.
研究组 & 干预措施
Macitentan
10 mg once daily
干预措施: Macitentan (Drug)
结局指标
主要结局
To assess the long-term safety of macitentan in patients with pulmonary arterial hypertension (PAH) beyond treatment in the AC-055-310 study.
时间窗: Baseline to end of treatment visit (around 6 months on average)
* Treatment-emergent adverse events (AEs) * AEs leading to premature discontinuation of study drug * Treatment-emergent serious adverse events (SAEs) * Proportion of patients with treatment-emergent ALT and/or AST abnormality (\> 3, \> 5, and \> 8 x ULN) associated or not with total bilirubin \> 2 x ULN. * Proportion of patients with treatment-emergent hemoglobin abnormality (≦ 100 g/L, and ≦ 80 g/L)
次要结局
未报告次要终点