Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension

Chronic Thromboembolic Pulmonary Hypertension Clinical Trial

— MERIT-2  

Official title:

MERIT-2 : Long Term, Multicenter, Single-arm, Open-label Extension Study of the MERIT-1 Study, to Assess the Safety, Tolerabilty and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02060721
• Other study ID #: AC-055E202
• Secondary ID: 2013-003457-25
• Status: Completed
• Phase: Phase 2
• Start date: February 3, 2015
• Est. completion date: March 21, 2022

Study information

• Verified date: March 2023
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: March 21, 2022
• Est. primary completion date: March 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent
• Subject with CTEPH having completed the double-blind (DB) AC-055E201/ MERIT-1 study as scheduled (i.e., who remained in the DB study up to Week 24).
• Females of childbearing potential must have a negative pre-treatment serum pregnancy test, be advised on appropriate methods of contraception, and agree to use 2 reliable methods of contraception.

Exclusion Criteria:

• Permanent discontinuation of DB study treatment due to an hepatic adverse event or liver aminotransferase abnormalities.
• Any known factor (e.g., drug or substance abuse) or disease (e.g., unstable psychiatric illness) that, in the opinion of the investigator, may interfere with treatment compliance or interpretation of the results, or that may influence the ability to comply with any of the study requirements.

Related Conditions & MeSH terms

• Chronic Thromboembolic Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary

Intervention

Drug:
• Macitentan
Macitentan 10mg, oral tablet, once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Countries where clinical trial is conducted

Belgium,  China,  Czechia,  France,  Germany,  Hungary,  Lithuania,  Mexico,  Poland,  Russian Federation,  Switzerland,  Thailand,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Primary	Number of Participants With AEs Leading to Study Drug Discontinuation	Number of participants with AEs leading to study drug discontinuation was reported.	Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Primary	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.	Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Primary	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.	Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Primary	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.	Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Primary	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.	Baseline and Month 6
Primary	Change From Baseline in Pulse Rate at Month 6	Change from baseline in pulse rate at Month 6 was reported.	Baseline and Month 6
Primary	Change From Baseline in Body Weight at Month 6	Change from baseline in body weight at Month 6 was reported.	Baseline and Month 6