EUCTR2019-004131-24-SK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
适应症
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
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 6 months prior to or during Screening.
- •Planned (during the double-blind period of the study) BPA.
- •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 DB period 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 Screening.
- •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, or, inhaled prostacyclins / prostacyclin analogs, or investigational treatment within 90 days prior to Randomization.
- •Administration of riociguat within 90 days prior to Randomization (if its use as background medication becomes permissible based on pharmacokinetic DDI data during the conduct of the study, this exclusion criterion will no longer apply).
- •Change in dose or initiation of PDE-5 inhibitors, oral prostacyclins / prostacyclin analogues, prostacyclin receptor agonists (or riociguat, if its use becomes permissible during the study) within 90 days prior to Randomization, or anticipated during the 52-week 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 Screening.
- •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 co-administration 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.
研究者
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