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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
151
macitentan 10 mg, film-coated tablet, oral use
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Day 1 to EoS visit (an average of 3 years)
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The Republican Scientific-Practical Center ''Cardiology''
Minsk, Belarus
UZ Leuven
Leuven, Belgium
CHRU Besancon Hopital Jean Minjoz
Besançon, France
CHU de Bordeaux - Hospital Haut-Leveque
Bordeaux (Pessac), France
CHU de la Cavale Blanche
Brest, France
GH est - Hôpital Cardiovasculaire et Pneumologie Louis Pradel
Bron, France
Hôpital Côte de Nacre
Caen, France
CHU Dijon
Dijon, France
CHU Grenoble
Grenoble, France
Hopital Bicetre Aphp Hopitaux Universitaires Paris Sud
Le Kremlin-Bicêtre, France
...and 24 more locations