A Clinical Study to Find Out if Macitentan is Effective and Safe in Japanese Patients With Chronic Thromboembolic Pulmonary Hypertension (CTEPH).

Study Purpose

The endothelin receptor antagonist macitentan showed significant improvement compared with placebo in pulmonary vascular resistance (PVR) and 6-minute walking distance (6MWD) in inoperable CTEPH patients in the phase II MERIT-1 trial (AC-055E201, NCT02021292). However, in the MERIT-1 trial Japanese patients were not included. Therefore, in line with Japan's medical environment, this phase III study is to confirm the efficacy and safety of macitentan in Japanese CTEPH patients.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 89 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Written informed consent to participate in the study obtained from the subject or legal representative a) prior to initiation of any study mandated procedure - Japanese subjects who have been diagnosed as having CTEPH: 1.

Subjects who have not undergone balloon pulmonary angioplasty (BPA) and for whom the investigator determines not to implement pulmonary endarterectomy (PEA) at the time of the acquisition of informed consent due to the organized thrombosis localized in the peripheral regions, high risk (complications, old age, etc.) or for any other reasons. 2. Subjects who have postoperative persistent or recurrent pulmonary hypertension (PH) after undergoing pulmonary endarterectomy (PEA) and/or BPA.

- PH subjects whose WHO FC is I to IV - 6MWD measured during the screening period ranges from 150 m to 450 m - Subjects who meet the following conditions according to the right heart catheterization (RHC) performed during the screening period or within 8 weeks before the acquisition of the informed consent: 1.

Resting mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg 2. Pulmonary artery wedge pressure (PAWP) ≤ 15 mmHg (if PAWP cannot be measured or the value of PAWP is not reliable, left ventricular end-diastolic pressure ≤ 13 mmHg) 3. Resting PVR ≥ 400 dyn*sec/cm5

- Subjects treated with anti-coagulation agents, unfractionated heparin or low molecular weight heparin at least 90 days prior to RHC at baseline - Women with childbearing potential with negative serum pregnancy test results and able to follow the appropriate contraceptive methods from the date of starting the study drug administration up to 30 days after the discontinuation or completion of the study drug administration.

Fertile male subjects able to use condom during the same period.

Exclusion Criteria:

- BPA within 90 days prior to undergoing baseline RHC - PEA within 180 days prior to undergoing baseline RHC - Subjects with unstable pulmonary hemodynamics who have postoperative persistent or recurrent PH after undergoing PEA and/or BPA - Recurrent thromboembolism undergoing treatment with oral anti-coagulation agents - Symptomatic acute pulmonary embolism within 180 days prior to the start of study drug administration - Known moderate-to-severe restrictive lung disease or obstructive lung disease or known significant chronic lung disease diagnosed by chest imaging (e.g., interstitial lung disease, emphysema) - Acute myocardial infarction during Screening period - Severe liver impairment.

- Systolic blood pressure (SBP) < 90 mmHg at screening.

- Any known factor or disease that may interfere with treatment compliance or full participation in the study

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03809650
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Actelion
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Yoshinari Yokoyama, PhD
Principal Investigator Affiliation	Actelion Japan
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry, Other
Overall Status	Recruiting
Countries	Japan
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Arms & Interventions

Arms

Experimental: Open-label treatment period

oral administration of macitentan 10 mg once daily

Interventions

Drug: - macitentan 10 mg

macitentan 10 mg, film-coated tablet, oral use

Contact a Trial Team

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International Sites

Fukuoka University Nishijin Hospital, Fukuoka, Japan

Status

Active, not recruiting

Address

Fukuoka University Nishijin Hospital

Fukuoka, , 814-8522

Site Contact

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