MERIT-2 : Long Term, Multicenter, Single-arm, Open-label Extension Study of the MERIT-1 Study, to Assess the Safety, Tolerabilty and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 主要终点
- Number of Participants With AEs Leading to Study Drug Discontinuation
研究概览
简要总结
Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Subject with CTEPH having completed the double-blind (DB) AC-055E201/ MERIT-1 study as scheduled (i.e., who remained in the DB study up to Week 24).
- •Females of childbearing potential must have a negative pre-treatment serum pregnancy test, be advised on appropriate methods of contraception, and agree to use 2 reliable methods of contraception.
排除标准
- •Permanent discontinuation of DB study treatment due to an hepatic adverse event or liver aminotransferase abnormalities.
- •Any known factor (e.g., drug or substance abuse) or disease (e.g., unstable psychiatric illness) that, in the opinion of the investigator, may interfere with treatment compliance or interpretation of the results, or that may influence the ability to comply with any of the study requirements.
研究组 & 干预措施
Macitentan
Macitentan 10mg, oral tablet, once daily
干预措施: Macitentan (Drug)
结局指标
主要结局
Number of Participants With AEs Leading to Study Drug Discontinuation
时间窗: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Number of participants with AEs leading to study drug discontinuation was reported.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
时间窗: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs are those events that started after administration of the first dose and up to safety follow-up visit/end of study, that is, 30 days after the last dose of study medication.
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
时间窗: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
A serious adverse event (SAE) is any untoward medical occurrence that at any dose resulting in any of following outcomes: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. Treatment-emergent SAEs were those events that started after administration of the first dose and up to safety follow-up visit/end of study, that is, 30 days after the last dose of study medication.
Number of Participants With Liver Tests Abnormalities
时间窗: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Number of participants with liver tests abnormalities were reported. It included alanine aminotransferase (ALT) or aspartate aminotransferase (AST): \>=3 x Upper limit of the normal range (ULN), \>=3 and \<5 x ULN, \>=5 ULN, and \>=5 and \<8 x ULN, \>= 8 x ULN, and total bilirubin \>=2 x ULN.
Change From Baseline in Pulse Rate at Month 6
时间窗: Baseline and Month 6
Change from baseline in pulse rate at Month 6 was reported.
Change From Baseline in Body Weight at Month 6
时间窗: Baseline and Month 6
Change from baseline in body weight at Month 6 was reported.
Number of Participants With Hemoglobin Abnormalities
时间窗: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Number of participants with hemoglobin abnormalities were reported. It included hemoglobin less than (\<) 80 grams per liter (g/L), hemoglobin \<100 g/L, hemoglobin greater than or equal to (\>=) 80 g/L and \<100 g/L, hemoglobin \<100g/L and a decrease of \>20 g/L from baseline, decrease of \>20 g/L in hemoglobin from baseline, decrease of \>20 g/L and \<=50 g/L in hemoglobin from baseline, and decrease of \>50 g/L in hemoglobin from baseline.
Change From Baseline in Blood Pressure at Month 6
时间窗: Baseline and Month 6
Change from baseline in blood pressure at Month 6 (both systolic blood pressure \[SBP\] and diastolic blood pressure \[DBP\]) was reported.
次要结局
未报告次要终点