EUCTR2019-004131-24-LT进行中（未招募）1 期
A prospective, randomized, double-blind, multicenter, placebo-controlled, parallel group, adaptive Phase 3 study with open-label extension to evaluate efficacy and safety of macitentan 75 mg in inoperable or persistent/recurrent chronic thromboembolic pulmonary hypertension. Macitentan in inoperAble or persistent/reCurrent chronIc ThromboEmbolic Pulmonary Hypertension (MACiTEPH) - MACiTEPH
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 230
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
- •Male or female = 18 (or the legal age of consent in the jurisdiction in which the study is taking place)and =80 years of age.
- •CTEPH (WHO Group 4) fulfilling one of the following criteria:
- •a. Inoperable due to the localization of the obstruction being surgically inaccessible (ie, distal disease) as confirmed by the adjudication committee (AC), and diagnosed based on
- •At least 2 of the following assessments in the 14 month-period prior to Randomization: Ventilation / Perfusion (V/Q) scan, pulmonary angiography (PA), computed tomography pulmonary angiogram (CTPA), magnetic resonance angiography (MRA).
- •- RHC at least 12 weeks after full anticoagulation showing the following (at Screening or in the 24 week period prior to Randomization): mPAP > 20 mmHg, PAWP =15 mmHg and PVR =240 dyn·sec/cm5.
- •b. Persistent/recurrent CTEPH after BPA, and deemed inoperable due to the localization of the obstruction being surgically inaccessible (ie, distal disease) as confirmed by the AC, diagnosed based on:
- •At least one of the following assessments performed after the latest BPA in the 14-month period prior to Randomization: V/Q scan, PA, CTPA or MRA
- •RHC at least 12 weeks after BPA and full anticoagulation showing the following (at Screening or in the 24-week period prior to Randomization): mPAP > 20 mmHg, PAWP =15 mmHg and PVR=240 dyn·sec/cm5.
- •c. Persistent/recurrent CTEPH after PEA (including PEA followed by BPA), diagnosed based on:
- •At least one of the following assessments performed after the PEA (and latest BPA following PEA, if applicable) in the 14-month period prior to Randomization: V/Q scan, PA, CTPA or MRA.
- •RHC performed at least 12 weeks after PEA (or latest BPA, if applicable) and full anticoagulationa showing the following (at Screening or in the 24 week period prior to Randomization): mPAP > 20 mmHg, PAWP =15 mmHg and PVR=240 dyn·sec/cm5.
- •6MWD = 100 m AND = 450 m, documented by an eligibility and a baseline 6MWT. The baseline 6MWD must not differ by more than 15% from the eligibility test.
- •WHO FC =II.
- •Participants are to receive riociguat as per local standard of care, unless it is contraindicated or unavailable
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •Acute pulmonary embolism within 3 months prior to or during
- •Planned BPA during the fixed duration part of the double-blind period
- •Significant obstructive and restrictive lung disease.
- •Acute or chronic conditions (other than dyspnea) that limit the ability to comply with study requirements, in particular with 6MWT (eg, intermittent claudication).
- •Symptomatic coronary artery disease requiring an intervention within 3 months prior to or during Screening or anticipated during the fixed duration part of the study.
- •Decompensated cardiac failure if not under close supervision.
- •Known and documented life-threatening cardiac arrhythmias.
- •Acute myocardial infarction within 6 months prior to, or during
- •Cerebrovascular events (including transient ischemic attack) within 3 months prior to, or during Screening.
- •Known or suspicion of pulmonary veno-occlusive disease (PVOD).
- •Administration of ERAs, intravenous prostacyclins / prostacyclin
- •analogs, or investigational treatment within 90 days prior to Randomization.
- •Change in dose or initiation of PDE-5 inhibitors, oral inhaled or SC
- •prostacyclins / prostacyclin analogues, prostacyclin receptor agonists
- •(or riociguat, within 90 days prior to Randomization, or anticipated
- •during the fixed duration part of the DB period.
- •Hypotension, ie, systolic blood pressure (SBP) <90 mmHg or diastolic blood pressure (DBP) <50 mmHg at Screening.
- •Severe renal dysfunction with an estimated Glomerular Filtration Rate <30 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration formula at Screening.
- •Known moderate to severe hepatic impairment, defined as Child-Pugh Class B or C, based on records that confirm documented medical history.
- •Serum aspartate aminotransferase (AST) and/or alanine
- •aminotransferase (ALT) =1.5 the upper limit of normal (ULN) at
- •Hemoglobin =100 g/L (<10 g/dL) at Screening.
- •Treatment with strong CYP3A4 inhibitors, (eg, ketoconazole,
- •itraconazole, voriconazole, clarithromycin, telithromycin, nefazodone,
- •ritonavir, and saquinavir) or moderate dual CYP3A4/CYP2C9 inhibitors (eg, fluconazole, amiodarone) or coadministration of a combination of moderate CYP3A4 (eg, ciprofloxacin, cyclosporine, diltiazem,erythromycin, verapamil) and moderate CYP2C9 inhibitors (eg, miconazole, piperine), within 30 days prior to Randomization.
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