EUCTR2018-004887-74-IT进行中（未招募）1 期
A multicenter, randomized, double-blind, placebo-controlled study in participants with sarcoidosis-associated pulmonary hypertension (SAPH) to assess the efficacy and safety of oral selexipag. - AC-065D301
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
- 74
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
- •1. Must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
- •2. Male or female. 3. 18 (or the legal age of consent in the jurisdiction in which the study is taking place) to 75 years of age, inclusive, at Screening.
- •4. Confirmed diagnosis of sarcoidosis as per ATS criteria. 5. Sarcoidosis-associated precapillary PH, confirmed by RHC (at rest) within 90 days prior to randomization:
- •a. PVR major or =320 dyn*sec/cm5 (major or =4.0 Wood units) b. Mean pulmonary artery pressure (mPAP) >or=25 mmHg c. Pulmonary artery wedge pressure (PAWP) 8. Criterion modified per Amendment 2. 8.1 Stable sarcoidosis treatment regimen, ie, no new specific antiinflammatory treatment for sarcoidosis for at least 90 days, and stable dose(s) for at least 30 days prior to both the RHC qualifying for enrollment and randomization.
- •9. 6MWD between 50 and 450m both at Screening and at the time of randomization.
- •10. Forced vital capacity (FVC) >50% of predicted at Screening.
- •11. FEV1/FVC >or=60%, or if FEV1/FVC <60% then FEV1 must be >or=60% of predicted at Screening.
- •12. For patients enrolling in the HRCT substudy only: clinical and/or radiological suspicion of pulmonary fibrosis.
- •13. For patients enrolled or planned to be enrolled in a cardio-pulmonary rehabilitation program based on exercise training, one of the following must apply:
- •In the maintenance phase of the program at the time of randomization with no plans to stop the program until Week 39, or
- •Start of the cardio-pulmonary rehabilitation program based on exercise training is planned after Week 39.
- •14. A woman must be (as defined in Appendix 5) - a. Not of childbearing potential b. Of childbearing potential and
- •o Have a negative highly sensitive serum (ß-human chorionic gonadotropin [ß-hCG]) at Screening and a negative urine pregnancy test at randomization.
- •o Agree to undertake monthly urine pregnancy tests during the study and up to at least 30 days after study intervention discontinuation.
- •o Practicing an acceptable method of contraception and agree to remain on an acceptable method while receiving study intervention and until 30 days after last dose of study intervention. Examples of acceptable methods of contraception are located in Appendix 5. 15. A woman using oral contraceptives must have been using this method for at least 1 month prior to randomization.
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •1. PH due to left heart disease (PAWP >15 mmHg).
- •2. PH due to compression of pulmonary arteries and/or pulmonary veins.
- •3. History of left heart failure (LHF) as assessed by the investigator including cardiomyopathies and cardiac sarcoidosis, with a left ventricular ejection fraction (LVEF) <40%.
- •4. Severe coronary heart disease (CHD) or unstable angina as assessed by the investigator.
- •5. Myocardial infarction within the last 6 months prior to or during Screening.
- •6. Criterion modified per Amendment 2.
- •6.1 Decompensated cardiac failure not receiving optimal medical treatment according to local guidelines.
- •7. Arrhythmias assessed as severe by the investigator.
- •8. Criterion modified per Amendment 2.
- •8.1 Implantable cardioverter defibrillator (ICD) for secondary prevention (current or planned).
- •9. Cerebrovascular events (eg, transient ischemic attack, stroke) within the last 90 days prior to or during Screening.
- •10. Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to PH.
- •11. Overt features of pulmonary veno-occlusive disease (PVOD).
- •12. Significant emphysema as assessed by the investigator.
- •13. Criterion modified per Amendment 2.
- •13.1 Known and documented severe hepatic impairment (eg. Child-Pugh C).
- •14. Severe renal failure (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2 or serum creatinine >2.5 mg/dL) based on central laboratory results from the Screening blood sample.
- •15. Criterion .modified per Amendment 2
- •15.1 Treatment with prostacyclin, prostacyclin analogues or IP receptor agonists (ie, selexipag) within 90 days prior to randomization and/or prior to the RHC qualifying for enrollment, except those given at vasodilator testing during RHC.
- •16. Included on a lung transplant list or planned to be included until Visit 6 / Week 39.
- •17. Known or suspected uncontrolled thyroid disease as per investigator judgment.
- •18. Treatment with moderate inducers of CYP2C8, eg rifampicin or strong inhibitors of CYP2C8, eg, gemfibrozil at or within 14 days prior to randomization.
- •19. Change in dose or initiation of new diuretics and/or calcium channel blockers within 1 week prior to RHC qualifying for enrollment.
- •20. SBP <90 mmHg at Screening or at randomization.
- •21. Known allergies, hypersensitivity, or intolerance to selexipag or its excipients (refer to Investigator’s Brochure).
- •22. Planned or current treatment with another investigational treatment up to 90 days prior to randomization.
- •23. Received an investigational intervention or used an invasive investigational medical device within 90 days prior to randomization.
- •24. Any condition for which, in the opinion of the investigator, participation would not be in the best interests of the participant (eg, compromise well-being), or that could prevent, limit, or confound the protocol-specified assessments.
- •25. Any acute or chronic impairment that may influence the ability to comply with study requirements such as to perform RHC, a reliable and reproducible 6MWT (eg, use of walking aids (cane, walker, etc.), or lung function tests.
- •26. Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator.
- •investigator or study site, as well as family members of the employees or
- •the investigator.
- •27. Pregnant or breast-feeding, or planning to become pregnant while enrolled in t
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