Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension - Clinical Trial for Chronic Thromboembolic Pulmonary Hypertension | NCT02060721

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Macitentan

About this trial

This is an interventional treatment trial for Chronic Thromboembolic Pulmonary Hypertension focused on measuring Chronic thromboembolic pulmonary hypertension (CTEPH)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Macitentan

Arm Description

Macitentan 10mg, oral tablet, once daily

Outcomes

Primary Outcome Measures

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.

Number of Participants With AEs Leading to Study Drug Discontinuation

Number of participants with AEs leading to study drug discontinuation was reported.

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.

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.

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.

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.

Change From Baseline in Pulse Rate at Month 6

Change from baseline in pulse rate at Month 6 was reported.

Change From Baseline in Body Weight at Month 6

Change from baseline in body weight at Month 6 was reported.

Secondary Outcome Measures

Full Information

NCT ID

NCT02060721

First Posted

January 2, 2014

Last Updated

March 17, 2023

Sponsor

Actelion

1. Study Identification

Unique Protocol Identification Number

NCT02060721

Brief Title

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

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

February 3, 2015 (Actual)

Primary Completion Date

March 21, 2022 (Actual)

Study Completion Date

March 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Actelion

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Thromboembolic Pulmonary Hypertension

Keywords

Chronic thromboembolic pulmonary hypertension (CTEPH)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Macitentan

Arm Type

Experimental

Arm Description

Macitentan 10mg, oral tablet, once daily

Intervention Type

Drug

Intervention Name(s)

Macitentan

Other Intervention Name(s)

ACT-064992

Intervention Description

Macitentan 10mg, oral tablet, once daily

Primary Outcome Measure Information:

Title

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Description

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