CTIS2023-506791-27-00招募中1 期
A Prospective, Open-label, Platform Study for Long-term Follow-up of Participants Using Study Intervention in Pulmonary Hypertension Parent Studies - NOPRODPAPUH3001
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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
入排标准
- 年龄范围
- 0 至 65+（—）
- 性别
- All
入选标准
- •Macitentan: 1. Participant must sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study. In case of enrollment of participants below 18 years old, parent(s) (preferably both if available or as per local requirements) must sign the ICF. Assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older) as described in Informed Consent Process in Master Protocol Section 10.2: Regulatory, Ethical, and Study Oversight Considerations, Macitentan: 2.1. Participant treated with oral macitentan at the end of a sponsor parent study and: a. The indication of the parent study is included in this ISA (PAH or CTEPH for adults, PAH for pediatric participants) b. Participant has completed the parent study c. No alternative means of access to study intervention (or equivalent approved therapy) have been identified d. Participant may continue to benefit from treatment with the study intervention e. Pediatric participant is at least 2 years old, Macitentan: A female participant of childbearing potential must: a. Have a negative urine or serum pregnancy test prior to first intake of study intervention, b. Agree to perform monthly urine pregnancy test up to the end of the safety follow-up period, c. Agree to follow contraceptive methods as defined in this ISA (Appendix A.3, Contraceptive and Barrier Guidance) until 30 days after the last intake of the study intervention., Selexipag: 1.1. Participant must sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study., Selexipag: 2.1. Participant treated with oral selexipag at the end of a sponsor parent study and: a. The indication of the parent study is included in this ISA (ie, PAH) b. Participant has completed the parent study c. No alternative means of access to study intervention (or equivalent approved therapy)have been identified d. Participant may continue to benefit from treatment with the study intervention, Selexipag: A female participant of childbearing potential must: a. Have a negative urine or serum pregnancy test prior to first intake of study intervention, b. Agree to perform monthly urine pregnancy test up to the end of the safety follow-up period, c. Agree to follow contraceptive methods as defined in this ISA (Appendix B.2, Contraceptive and Barrier Guidance) until 30 days after the last intake of the study intervention., Fixed-dose combination: 1.1. Participant must sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study., Fixed-dose combination: 2.1. Participant treated with FDC of macitentan 10 mg and tadalafil 40 mg at the end of a sponsor parent study and: a. The indication of the parent study is included in this ISA (ie, PAH) b. Participant has completed the parent study c. No alternative means of access to study intervention (or equivalent approved therapy) have been identified d. Participant may continue to benefit from treatment with the study intervention, Fixed-dose combination: A female participant of childbearing pote
排除标准
- •1.1. Participants prematurely discontinued the study intervention in their parent study (participant’s or investigator’s decision)., Macitentan: 7.1. Systemic treatment with a strong CYP3A4 inducer (eg, rifabutin, rifampin, rifampicin, rifapentin, carbamazepine, phenobarbital, phenytoin, St. John’s Wort) within 1 month prior to baseline., Macitentan: Interruption of study intervention for more than 4 weeks since the last dose of study intervention taken in the parent study, Macitentan: Treatment with an ERA (other than the study intervention)., Selexipag: Known allergies, hypersensitivity, or intolerance to selexipag or its excipients (refer to selexipag IB), Selexipag: Suspected or known pulmonary veno-occlusive disease (PVOD), Selexipag: Uncontrolled thyroid disease, Selexipag: Severe coronary heart disease or unstable angina, myocardial infarction within the last 6 months, decompensated cardiac failure (if not under close medical supervision), severe arrhythmia, cerebrovascular events (eg, transient ischemic attack, stroke) within the last 3 months, or congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to PH., Selexipag: Known and documented severe hepatic impairment ie, Child-Pugh Class C. For participants with hepatic impairment, Child-Pugh Class (Child-Pugh Score, Section 10.6) should be fully assessed and documented in the source documents at Screening, Selexipag: Any disallowed therapy as noted in Section Concomitant Therapy”: • treatment with a strong CYP2C8 inhibitor (eg, gemfibrozil) • treatment with oral prostacyclin analogs (eg, beraprost, treprostinil) since the last dose of study intervention taken in the parent study • any investigational treatment other than selexipag, Selexipag: Renal impairment: End-stage renal impairment (estimated glomerular filtration rate [eGFR] by Modification of Diet in Renal Disease [MDRD] formula, Female participant being pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study., Fixed-dose combination: Known allergies, hypersensitivity, or intolerance to macitentan or tadalafil or their excipients (refer to the macitentan/tadalafil FDC IB)., Fixed-dose combination: Hemoglobin <80 g/L. Participants with hemoglobin <80 g/L at Enrollment are allowed to enter the study at the discretion of the investigator provided they meet all inclusion criteria. Study treatment is to be initiated as soon as their hemoglobin is =80 g/L, assuming it is within the allowed treatment interruption period, Fixed-dose combination: Serum aspartate (AST) and/or alanine aminotransferases (ALT)>3×ULN range. Participants with serum AST and/ or ALT >3×ULN at Enrollment are allowed to enter the study at the discretion of the investigator, provided they meet all inclusion criteria, as long as the liver chemistry abnormality does not meet one of the permanent discontinuation criteria listed for this ISA. Study treatment is to be initiated as soon as their serum AST and/or ALT is =3×ULN, assuming it is within the allowed treatment interruption period., Fixed-dose combination: Known and documented severe hepatic impairment ie, Child-Pugh Class C. For participants with hepatic impairment, Child-Pugh Class (Child-Pugh Score, Section 10.6) should be fully assessed and documented in the source documents at Screening., Fixed-dose combination: Severe renal impairment (estimated glomerular filtration rate (eGFR)/creatinine clearance <30 mL/min), Fix
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