EUCTR2021-002297-11-BG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 - PLATYPUS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 390
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
- •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.
- •2. Participant treated with 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
- •3. A woman 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 ISA (Appendix B.2, Contraceptive and Barrier Guidance) until 30 days after the last intake of the study intervention.
- •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
- •2.Participant treated with macitentan 10 mg 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
- •d) Participant may continue to benefit from treatment with the study
- •intervention
- •e. Pediatric participant is at least 2 years old
- •3. A woman 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.
- •Fixed Dose Combination of macitentan + tadalafil
- •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.
- •2.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
- •d. Participant may continue to benefit from treatment with the study
- •intervention
- •3. A woman 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,
排除标准
- •General exclusion criteria
- •1. Participants prematurely discontinued the study intervention in their parent study (participant’s or investigator’s decision).
- •2. Female participant being pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study.
- •3. Planned or current treatment with another investigational treatment.
- •Selexipag exclusion criteria
- •1. Known allergies, hypersensitivity, or intolerance to selexipag or its excipients (refer to selexipag IB)
- •2. Suspected or known pulmonary veno-occlusive disease (PVOD)
- •3. Uncontrolled thyroid disease
- •4. 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
- •5. Known and documented severe hepatic impairment ie, Child-Pugh Class C. For participants with hepatic impairment, Child-Pugh Class should be fully assessed and documented in the source documents at
- •6. 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
- •7. Renal impairment: End-stage renal impairment (estimated glomerular filtration rate [eGFR] by Modification of Diet in Renal Disease [MDRD] formula <15 mL/min/1.73 m2) or planned dialysis.
- •Macitentan exclusion criteria
- •1. Known allergies, hypersensitivity, or intolerance to macitentan or its excipients (refer to the macitentan IB).
- •2. Hemoglobin 3×ULN.
- •3. Serum aspartate (AST) and/or alanine aminotransferases (ALT) >3 ×
- •the upper limit of normal (ULN) range.
- •4. Known and documented severe hepatic impairment ie, Child-Pugh
- •Class C. For participants with hepatic impairment, Child-Pugh Class
- •should be fully assessed and documented in the source documents at
- •5. Treatment with a strong cytochrome P450 (CYP)3A4 inhibitor (eg,
- •ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir, and saquinavir).
- •6. Treatment with a moderate dual CYP3A4/CYP2C9 inhibitor (eg,
- •fluconazole, amiodarone) or uses a co-administration of a combination of moderate CYP3A4 (eg ciprofloxacin, cyclosporine, diltiazem, erythromycin, verapamil) and moderate CYP2C9 inhibitors (eg, miconazole, piperine). If a participant coming from a parent
- •study is currently under such a concomitant treatment, the participant may be enrolled as per the investigator's discretion based on his/her clinical judgement and risk-benefit assessment.
- •7. Treatment with a strong CYP3A4 inducer (eg, rifabutin, rifampin,
- •rifampicin, rifapentin, carbamazepine, phenobarbital, phenytoin, St.
- •John's Wort) within 1 month prior to baseline.
- •8. Interruption of study intervention for more than 4 weeks since the
- •last dose of study intervention taken in the parent study.
- •9. Treatment with an ERA (other than the study intervention).
- •Macitentan and Tadalafil exclusion criteria:
- •1. Known allergies, hypersensitivity, or intolerance to macitentan or
- •tadalafil or their excipients
- •2. Hemoglobin
- •3. Serum aspartate (AST) and/or alanine aminotransferases (ALT) >3 ×
- •the upper limit of norm
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