Pulmonary Hypertension MedDRA version: 21.1 Level: PT Classification code 10037400 Term: Pulmonary hypertension System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Opsumit
Product Name: Macitentan
Product Code: JNJ-67896062
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Macitentan
CAS Number: 441798-33-0
Current Sponsor code: JNJ-67896
Sponsors
Actelion Pharmaceuticals Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 identified 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 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 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 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: 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 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 Screening. 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 Class C. 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 may be enrolled as per the investigator's discretion based on his/her clinical judgment and risk-benefit assessment. 9. Treatment with a strong CYP3A4 inducer (eg, rifabutin, rifampin, rifampicin, rifapentin, carbamazepine, phenobarbital, phenytoin, St. John’s Wort) within 1 month prior to baseline. 10. Treatment with doxazosin 11. Treatment with any form of organic nitrate, either regularly or intermittently. 12. T
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety of the respective study interventions in treated participants ;Secondary Objective: Secondary objectives of the trial are not applicable ;Primary end point(s): Frequency of treatment-emergent adverse events (AEs), treatment-emergent AEs leading to discontinuation, serious adverse events (SAEs), and/or deaths ;Timepoint(s) of evaluation of this end point: from baseline until End-of-Study (EOS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints not applicable. ;Timepoint(s) of evaluation of this end point: Secondary endpoints not applicable. | — |
Countries
Belarus, Belgium, Bulgaria, China, France, India, Korea, Republic of, Poland, Romania, Russian Federation, South Africa, Taiwan, Türkiye, Ukraine
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed