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

NCT ID: NCT03809650

Last Updated: 2021-06-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-08
• Study Completion Date: 2020-06-29

Brief Summary

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.

Conditions

Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Open-label treatment period

oral administration of macitentan 10 mg once daily

Group Type: EXPERIMENTAL

macitentan 10 mg

Intervention Type: DRUG

macitentan 10 mg, film-coated tablet, oral use

Interventions

macitentan 10 mg

macitentan 10 mg, film-coated tablet, oral use

Intervention Type: DRUG

Other Intervention Names

ACT-064992, Opsumit®

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EPS Corporation

OTHER

Sponsor Role: collaborator

Imepro Inc.

UNKNOWN

Sponsor Role: collaborator

General Laboratory, BML, Inc.

UNKNOWN

Sponsor Role: collaborator

Mitsubishi Logistics Corporation

UNKNOWN

Sponsor Role: collaborator

Actelion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yoshinari Yokoyama, PhD

Role: STUDY_DIRECTOR

Actelion Japan

Locations

Fukuoka University Nishijin Hospital

Fukuoka, , Japan

Fukushima Medical University Hospital

Fukushima, , Japan

Kagoshima University Hospital

Kagoshima, , Japan

Nara Medical University Hospital

Kashihara, , Japan

Kokura Kinen Hospital

Kitakyushu, , Japan

Kobe University Hospital

Kobe, , Japan

Saitama Cardiovascular and Respiratory Center

Kumagaya, , Japan

Kure Kyosai Hospital

Kure, , Japan

Kurume University Hospital

Kurume, , Japan

Toho University Ohashi Medical Center

Meguro-ku, , Japan

IIUHW Mita Hospital

Minatoku, , Japan

Kyorin University Hospital

Mitaka, , Japan

Nagasaki University Hospital

Nagasaki, , Japan

National Hospital Organization Okayama Medical Center

Okayama, , Japan

Sapporo Medical University Hospital

Sapporo, , Japan

Hokkaido University Hospital

Sapporo, , Japan

Sasebo City General Hospital

Sasebo, , Japan

Keio University Hospital

Shinjuku-ku, , Japan

National Cerebral and Cardiovascular Center Hospital

Suita, , Japan

Mie University Hospital

Tsu, , Japan

University of Tsukuba Hospital

Tsukuba, , Japan

Yamagata University Hospital

Yamagata, , Japan

Yokohama City University Hospital

Yokohama, , Japan

Countries

Japan

Related Links

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217051&amp;parentIdentifier=AC-055E301&amp;attachmentIdentifier=aa227840-255d-4f06-8064-e8ebb89a846a&amp;fileName=AC-055E301_CSR_Synopsis.pdf&amp;versionIdentifier=

A Prospective, Multicenter, Open-label, Single Arm, Phase III Study to Assess the Efficacy and Safety of Macitentan (ACT-064992) in Subjects With Chronic Thromboembolic Pulmonary Hypertension (CTEPH)

Other Identifiers

AC-055E301

Identifier Type: -

Identifier Source: org_study_id