EUCTR2021-002297-11-PL进行中（未招募）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
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 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
- •2.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
- •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,
- •c. Agree to follow contraceptive methods as defined in this ISA
- •(Appendix C.3, Contraceptive and Barrier Guidance) until 30 days after
- •the last intake of the study intervention
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 80
- 另有 4 项未显示
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.
- •Macitentan exclusion criteria
- •1. Known allergies, hypersensitivity, or intolerance to macitentan or its
- •excipients (refer to the macitentan IB).
- •2. Hemoglobin <80 g/l.
- •3. Serum aspartate (AST) and/or alanine aminotransferases (ALT) >3 ×(ULN) .
- •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. Systemic 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. 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.
- •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 ×
- •(ULN) range.
- •4. Known and documented severe hepatic impairment ie, Child-Pugh
- •5. Severe renal impairment (estimated glomerular filtration rate (eGFR)/creatinine clearance
- •6. Loss of vision in one or both eyes because of non-arteritic anterior ischemic optic
- •neuropathy, regardless of whether or not this episode was in connection with
- •phosphodiesterase type 5 inhibitor treatment (tadalafil).
- •7. Systemic treatment with a strong CYP3A4 inhibitor (eg, ketoconazole,
- •itraconazole, voriconazole, clarithromycin, telithromycin, nefazodone, ritonavir,
- •and saquinavir).
- •8. Systemic 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
- 另有 7 项未显示
研究者
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