EUCTR2010-024211-13-ES进行中（未招募）1 期
ong term, single-arm, open-label extension study of the MUSIC study toassess the safety and tolerability of macitentan in patients with idiopathic pulmonary fibrosis - MUSIC O
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 178
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
- •- Signed informed consent prior to initiation of any study-related
- •- Patients with IPF and having completed the double-blind AC-
- •055B201/MUSIC study as scheduled, i.e., having remained in the study
- •until the sponsor-declared end-of study, whether or not study treatment
- •was prematurely discontinued.
- •- Women of childbearing potential must have a negative pre-treatment
- •serum pregnancy test and must use a reliable method of contraception
- •during study treatment and for at least 28 days after study treatment
- •termination.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 65
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 113
排除标准
- •- Any major violation of protocol AC-055B201/MUSIC.
- •- Premature discontinuation of study treatment during the AC-
- •055B201/MUSIC study due to an adverse event (AE) assessed as related
- •to the use of macitentan, excluding events of IPF worsening.
- •- Pregnancy or breast-feeding.
- •- AST and/or ALT > 3 times the upper limit of the normal range.
- •- Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug
- •or alcohol dependence or psychiatric disease.
- •- Known hypersensitivity to drugs of the same class as macitentan, or
- •any of the excipients.
研究者
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