Long-term study to evaluate if macitentan is safe, tolerable and efficient enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (CTEPH)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
76
Macitentan 10mg, oral tablet, once daily
Unnamed facility
Leuven, Belgium
Unnamed facility
Beijing, China
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs are those events that started after administration of the first dose and up to safety follow-up visit/end of study, that is, 30 days after the last dose of study medication.
Time frame: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Number of Participants With AEs Leading to Study Drug Discontinuation
Number of participants with AEs leading to study drug discontinuation was reported.
Time frame: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
A serious adverse event (SAE) is any untoward medical occurrence that at any dose resulting in any of following outcomes: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. Treatment-emergent SAEs were those events that started after administration of the first dose and up to safety follow-up visit/end of study, that is, 30 days after the last dose of study medication.
Time frame: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Number of Participants With Hemoglobin Abnormalities
Number of participants with hemoglobin abnormalities were reported. It included hemoglobin less than (\<) 80 grams per liter (g/L), hemoglobin \<100 g/L, hemoglobin greater than or equal to (\>=) 80 g/L and \<100 g/L, hemoglobin \<100g/L and a decrease of \>20 g/L from baseline, decrease of \>20 g/L in hemoglobin from baseline, decrease of \>20 g/L and \<=50 g/L in hemoglobin from baseline, and decrease of \>50 g/L in hemoglobin from baseline.
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Unnamed facility
Guangzhou, China
Unnamed facility
Shanghai, China
Unnamed facility
Shenyang, China
Unnamed facility
Wuhan, China
Unnamed facility
Prague, Czechia
Unnamed facility
Le Kremlin-Bicêtre, France
Unnamed facility
Paris, France
Unnamed facility
Toulouse, France
...and 23 more locations
Time frame: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Number of Participants With Liver Tests Abnormalities
Number of participants with liver tests abnormalities were reported. It included alanine aminotransferase (ALT) or aspartate aminotransferase (AST): \>=3 x Upper limit of the normal range (ULN), \>=3 and \<5 x ULN, \>=5 ULN, and \>=5 and \<8 x ULN, \>= 8 x ULN, and total bilirubin \>=2 x ULN.
Time frame: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Change From Baseline in Blood Pressure at Month 6
Change from baseline in blood pressure at Month 6 (both systolic blood pressure \[SBP\] and diastolic blood pressure \[DBP\]) was reported.
Time frame: Baseline and Month 6
Change From Baseline in Pulse Rate at Month 6
Change from baseline in pulse rate at Month 6 was reported.
Time frame: Baseline and Month 6
Change From Baseline in Body Weight at Month 6
Change from baseline in body weight at Month 6 was reported.
Time frame: Baseline and Month 6