A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension

  • STATUS
    Recruiting
  • End date
    Aug 12, 2026
  • participants needed
    144
  • sponsor
    Actelion
Updated on 4 December 2020
macitentan

Summary

The purpose of the study is to evaluate the effect of macitentan 75 mg versus placebo on exercise capacity at Week 28 in participants with chronic thromboembolic pulmonary hypertension (CTEPH).

Description

CTEPH is one of the leading causes of severe pulmonary hypertension (PH), classified within World Health Organization (WHO) group 4 PH. It is a rare, progressive pulmonary vascular disease that if left untreated, leads to progressively increasing pulmonary vascular resistance (PVR) and eventually right ventricle failure and death. Histopathologic findings including endothelial cell dysfunction and distal pulmonary arterial remodeling are shared between PAH and CTEPH, and PH-specific therapies (that is, riociguat) have shown efficacy in inoperable and persistent/recurrent CTEPH. The endothelin receptor antagonist macitentan offers a different mode of action and addresses an important unmet medical need for an alternative treatment option in this indication. This study will assess the effect of macitentan 75 mg on exercise capacity and is expected to confirm the role of macitentan as a first line, as well as add-on treatment for CTEPH. The study comprises of screening period (at least 14- and up to 60 days), a 52-week double-blind (DB) treatment period (which includes an 8-week up-titration phase), an open-label (OL) extension period (which starts at Week 52 and will end for all participants 104 weeks after the last participant has completed the DB treatment period) and 30-day safety follow-up period. Participants who discontinue DB study intervention will be followed until Week 52 in a post-treatment-observation period (PTOP). The total duration of the study is approximately 6 years.

Details
Treatment Placebo, Macitentan
Clinical Study IdentifierNCT04271475
SponsorActelion
Last Modified on4 December 2020

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Eligibility

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Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have Chronic Thromboembolic Pulmonary Hypertension?
Do you have any of these conditions: Chronic Thromboembolic Pulmonary Hypertension or thromboembolic pulmonary hypertension or CTEPH?
Do you have any of these conditions: thromboembolic pulmonary hypertension or Chronic Thromboembolic Pulmonary Hypertension or CTEPH?
Chronic thromboembolic pulmonary hypertension (CTEPH) (World Health Organization [WHO] Group 4) fulfilling one of the following criteria: a) inoperable due to the localization of the obstruction being surgically inaccessible (that is, distal disease), b) persistent/recurrent CTEPH after balloon pulmonary angioplasty (BPA), and deemed inoperable due to the localization of the obstruction being surgically inaccessible (that is, distal disease), c) persistent/recurrent CTEPH after rescue pulmonary endarterectomy (PEA)
-minute walk distance (6MWD) greater than or equal to (>=) 100 meter (m) and less than or equal to (<=) 450 meters (m), documented by an eligibility and a baseline 6-minute walk test (6MWT). The baseline 6MWD must not differ by more than 15 percent (%) from the eligibility test
World Health Organization functional class (WHO FC) >= II
Participants are to receive riociguat as per local standard of care, unless it is contraindicated or unavailable

Exclusion Criteria

Acute pulmonary embolism within 6 months prior to or during Screening
Planned (during the double-blind period of the study) balloon pulmonary angioplasty (BPA)
Significant obstructive and restrictive lung disease
Acute or chronic conditions (other than dyspnea) that limit the ability to comply with study requirements, in particular with 6MWT (for example, intermittent claudication)
Symptomatic coronary artery disease requiring an intervention within 3 months prior to or during Screening or anticipated during the DB period of the study
Decompensated cardiac failure if not under close supervision
Known and documented life-threatening cardiac arrhythmias
Acute myocardial infarction within 6 months prior to, or during Screening
Cerebrovascular events (including transient ischemic attack) within 3 months prior to, or during Screening
Known or suspicion of pulmonary veno-occlusive disease (PVOD)
Administration of ERAs, intravenous, or inhaled prostacyclins / prostacyclin analogs, or investigational treatment within 90 days prior to Randomization
Administration of riociguat within 90 days prior to Randomization (if its use as background medication becomes permissible based on pharmacokinetic Drug-drug interaction [DDI] data during the conduct of the study, this exclusion criterion will no longer apply)
Change in dose or initiation of Phosphodiesterase type-5 (PDE-5) inhibitors, oral prostacyclins / prostacyclin analogues, prostacyclin receptor agonists (or riociguat, if its use becomes permissible during the study) within 90 days prior to Randomization or anticipated during the 52-week double-blind [DB] period
Hypotension, that is, systolic blood pressure (SBP) less than (<) 90 millimeters of mercury (mmHg) or diastolic blood pressure (DBP) <50 mmHg at Screening
Severe renal dysfunction with an estimated Glomerular Filtration Rate <30 milliliters per minute per 1.73 meter square (mL/min/1.73 m^2) using the Chronic Kidney Disease Epidemiology Collaboration formula at Screening
Known moderate to severe hepatic impairment, defined as Child-Pugh Class B or C, based on records that confirm documented medical history
Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) greater than or equal to (>=) 1.5upper limit of normal (ULN) at Screening
Hemoglobin <100 g/L (<10 gram per deciliter [g/dL]) at Screening
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