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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-003934-10 | EudraCT Number |
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The aim of the trial is to study the long-term safety of macitentan and to provide continued treatment with macitentan to patients with pulmonary arterial hypertension (PAH) and Chronic thromboembolic pulmonary hypertension (CTEPH) who were previously treated with macitentan in clinical studies.
The purpose of this study is to provide continued treatment with macitentan to subjects with PAH or CTEPH who participated in "parent studies" and to continue to accrue long-term safety data. The design of this study is widely used in clinical programs to give participants in a clinical study access to an effective study treatment beyond completion of the parent study. This is considered the best option to collect long-term safety and tolerability information of macitentan 10 mg and survival status of participants with PAH and CTEPH. "Parent study/studies" refer to a number of clinical studies with macitentan that are conducted in different clinical classification of PAH and CTEPH (NCT00667823, NCT02112487, NCT02310672, NCT02968901, NCT02558231, NCT02382016, NCT02060721) and may be completed before the participants have access to commercial macitentan in their country of residence. The "parent studies" are fully or partially running in countries where no access to commercial macitentan is expected in the near future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label macitentan 10 mg | Experimental | 10 mg macitentan film coated tablet, administered orally once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| macitentan | Drug | macitentan 10 mg, film-coated tablet, oral use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incident Rate of Treatment-emergent Adverse Event | An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. A treatment-emergent AE is any AE temporally associated with the use of study treatment. | From Day 1 to End of study (EoS) visit (an average of 3 years) |
| Incident rate of treatment-emergent adverse events (AEs) leading to premature discontinuation of study treatment | Any AE will be recorded that 1) is (temporally) associated with the use of study treatment whether or not considered by the investigator as related to study treatment and 2) leads to premature discontinuation of study medication. | From Day 1 to EoS visit (an average of 3 years) |
| Incident rate of treatment-emergent serious adverse events (SAEs) | Any SAE as defined by the ICH guidelines will be recorded. Any hepatic AE that leads to discontinuation of study treatment will be defined as SAE. | From Day 1 to EoS visit (an average of 3 years) |
| Number of pregnancies with maternal exposure to macitentan | Pregnancies with maternal exposure to macitentan will be recorded. | From Day 1 to EoS visit (an average of 3 years) |
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| Measure | Description | Time Frame |
|---|---|---|
| Change of WHO functional class to each scheduled time point | The proportion of patients who worsened, remain unchanged or improved from baseline to each scheduled time-point in WHO function will be calculated, where baseline is the initial baseline from the "parent study" (or the double-blind core study preceding the "parent study"). | From Day 1 to EoT visit (an average of 3 years) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marek Sochor | Actelion | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Republican Scientific-Practical Center ''Cardiology'' | Minsk | 220036 | Belarus | |||
| UZ Leuven |
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The study is designed as an open-label, single-arm, multicenter trial in which all participants roll over from a "parent study" in order to continue their dose of macitentan 10 mg once every day as already received in the "parent study".
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| Assessment of survival status at End-of-Study (EoS) | Time to death of all causes up to EoS from the date of randomization or enrollment in the "parent study" (or the double-blind core study preceding the "parent study") will be estimated. | From Day 1 to EoS visit (an average of 3 years) |
| Leuven |
| 3000 |
| Belgium |
| CHRU Besancon Hopital Jean Minjoz | Besançon | 25030 | France |
| CHU de Bordeaux - Hospital Haut-Leveque | Bordeaux (Pessac) | 33604 | France |
| CHU de la Cavale Blanche | Brest | 29609 | France |
| GH est - Hôpital Cardiovasculaire et Pneumologie Louis Pradel | Bron | 69677 | France |
| Hôpital Côte de Nacre | Caen | France |
| CHU Dijon | Dijon | 21079 | France |
| CHU Grenoble | Grenoble | 38700 | France |
| Hopital Bicetre Aphp Hopitaux Universitaires Paris Sud | Le Kremlin-Bicêtre | 94275 | France |
| Hôpital Cardiologique - Chru Lille | Lille | 59037 | France |
| CHU de Limoges | Limoges | 87042 | France |
| CHU de la Timone | Marseille | 13005 | France |
| CHU de Montpellier - Arnaud de Villeneuve | Montpellier | 34295 | France |
| CHU Nantes - Hopital Nord Laënnec | Nantes | 44093 | France |
| Centre Hospitalier Universitaire - de Nice - Hopital Pasteur | Nice | 06001 | France |
| Hopital Europeen Georges Pompidou | Paris | 75908 | France |
| CHU de Reims | Reims | 51100 | France |
| Chu Rennes Hopital Pontchaillou | Rennes | 35033 | France |
| CHU Rouen Hopital Charles Nicolle | Rouen | 76031 | France |
| CHU Saint Etienne Hopital Nord | Saint-Priest-en-Jarez | 42277 | France |
| Nouvel Hopital Civil | Strasbourg | 67091 | France |
| Hopital Larrey CHU de Toulouse | Toulouse | France |
| CHU de Nancy - Hopital de Brabois | Vandœuvre-lès-Nancy | 54511 | France |
| Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego SPZOZ | Lublin | 20 718 | Poland |
| Wojewodzki Szpital Specjalistyczny Oddzial Kardiologiczny | Wroclaw | 51 124 | Poland |
| Cardiovascular Pathology Research Institute of Siberian Branch of RAMS | Kemerovo | 650002 | Russia |
| National Medical Research Center of Cardiology of MoH of Russian Federation | Moscow | 121552 | Russia |
| Federal State Budgetary Institution Of Ministry Of Health Of Russian Federation | Novosibirsk | 630055 | Russia |
| Federal North-West Medical Research Centre | Saint Petersburg | 197341 | Russia |
| Federal State Budget Scientific Institution | Tomsk | 634012 | Russia |
| Istanbul University Istanbul Medical Faculty | Capa_Istanbul | 34093 | Turkey (Türkiye) |
| CE 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiosurgery' | Dnipro | 49059 | Ukraine |
| Lviv Regional Clinical Hospital | Lviv | 79000 | Ukraine |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C533860 | macitentan |
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