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Chronic Thromboembolic Pulmonary Hypertension (CTEPH)Phase 3NCT03809650

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

A Phase 3 study testing macitentan 10 mg in people with Chronic Thromboembolic Pulmonary Hypertension (CTEPH), run by Actelion at 23 sites in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 89 years
What is being tested?
macitentan 10 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
23 sitesJapan
Study dates
8 Jan 2019to 29 Jun 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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.
  • 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
Show all 12Show fewer
  • 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:
  • Resting mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg
  • 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)
  • 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.

Who cannot join

  • 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)
Show all 10Show fewer
  • 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 locations and contacts

23 sites in 1 country.

23 sites in 1 country

Japan23 sites

  • Fukuoka University Nishijin Hospital

    Fukuoka, 814-8522

  • Fukushima Medical University Hospital

    Fukushima, 960-1247

  • Kagoshima University Hospital

    Kagoshima, 890-8520

  • Nara Medical University Hospital

    Kashihara, 634-8522

  • Kokura Kinen Hospital

    Kitakyushu, 802-8555

  • Kobe University Hospital

    Kobe, 650-0017

  • Saitama Cardiovascular and Respiratory Center

    Kumagaya, 360-0197

  • Kure Kyosai Hospital

    Kure, 737-8505

  • Kurume University Hospital

    Kurume, 830-0011

  • Toho University Ohashi Medical Center

    Meguro-ku, 153-8515

  • IIUHW Mita Hospital

    Minatoku, 108-8329

  • Kyorin University Hospital

    Mitaka, 181-8611

  • Nagasaki University Hospital

    Nagasaki, 852-8501

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192

  • Sapporo Medical University Hospital

    Sapporo, 060-8543

  • Hokkaido University Hospital

    Sapporo, 060-8648

  • Sasebo City General Hospital

    Sasebo, 857-8511

  • Keio University Hospital

    Shinjuku-ku, 160-0016

  • National Cerebral and Cardiovascular Center Hospital

    Suita, 565-8565

  • Mie University Hospital

    Tsu, 514-8507

  • University of Tsukuba Hospital

    Tsukuba, 305-8576

  • Yamagata University Hospital

    Yamagata, 990-0828

  • Yokohama City University Hospital

    Yokohama, 236-0004

Other trials in Japan

About this study

Official title: 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)

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.

Being tested
macitentan 10 mg
Keywords
CTEPH, chronic thromboembolic pulmonary hypertension, macitentan

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • macitentan 10 mgDrug

    Also called ACT-064992, Opsumit®

    macitentan 10 mg, film-coated tablet, oral use

Study groups in NCT03809650
Study groupRoleWhat they receive
Open-label treatment periodExperimentaloral administration of macitentan 10 mg once daily
Receives: Drug: macitentan 10 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the ratio in pulmonary vascular resistance (PVR) at rest from baseline to Week 16

    The resistance in the artery carrying blood to the lungs is called PVR. The PVR is the resistance in the artery carrying blood to the lungs and that has to be overcome by the right ventricle in heart in order to let blood flow to the lungs occur. The ratio in PVR at rest indicates the efficacy of macitentan in patients with CTEPH. The ratio in PVR at rest is calculated as PVR at Week 16 divided by baseline PVR. The ratio in PVR at rest from baseline to Week 16 of administration of macitentan is evaluated in subjects with CTEPH who are not indicated for pulmonary endarterectomy (PEA) and/or subjects who have postoperative persistent or recurrent pulmonary hypertension (PH) after PEA and/or balloon pulmonary angioplasty (BPA).

    Measured: From Baseline to Week 16

Secondary outcomes (5)

  1. Change from baseline to Week 16 in PVR at rest

    The PVR at rest will be calculated to evaluate the change in PVR at rest from pre-dosing (baseline) to post-dosing (Week 16).

    Measured: From baseline to Week 16

  2. Change from baseline to Week 16 in pulmonary vascular resistance index (PVRI) at rest

    The indexed PVR (PVRI) at rest will be calculated to evaluate the change in PVRI at rest from pre-dosing (baseline) to post-dosing (Week 16).

    Measured: From baseline to Week 16

  3. Change from baseline to Week 24 in 6-minute walk distance (6MWD)

    The purpose of the 6-minute walk is to test exercise tolerance and capacity. The test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. This endpoint evaluates the change in 6MWD from pre-dosing (baseline) to post-dosing (Week 24).

    Measured: From baseline to Week 24

  4. Change from baseline to Week 24 in Borg dyspnea index

    The Borg dyspnea index rates the severity of dyspnea (difficult or labored breathing) on a scale from 0 ('Nothing at all') to 10 ('Very, very severe - maximal'). A decrease in the Borg dyspnea index indicates an improvement. This endpoint evaluates the change in the Borg dyspnea index assessed at the end of measuring the 6MWD from pre-dosing (baseline) to post-dosing (Week 24).

    Measured: From baseline to Week 24

  5. Change from baseline to Week 24 in WHO functional class (WHO FC)

    This endpoint evaluates the change of WHO functional class from pre-dosing (baseline) to post-dosing (Week 24). Class I: no symptoms with exercise or at rest. No limitation of activity. Class II: No symptoms at rest but slight limitation with ordinary activities causing symptoms (e.g. short of breath with climbing a flight of stairs, grocery shopping, or making the bed). Class III: may not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting. Class IV: symptoms at rest (e.g. dyspnea and/or fatigue) and inability to carry out any physical activity without symptoms. Patients in class IV manifest signs of right heart failure.

    Measured: From baseline to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2019
  2. Study start8 Jan 2019
  3. Primary completion29 Jun 2020
  4. Study completion29 Jun 2020

Why it stopped: Due to a change in the development strategy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03809650
Sponsor's protocol ID
AC-055E301
Status last verified
Mar 2021
First submitted
10 Jan 2019
Last updated
18 Jun 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials\\transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Access (YODA) Project site at yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing macitentan 10 mg in people with Chronic Thromboembolic Pulmonary Hypertension (CTEPH), run by Actelion at 23 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Due to a change in the development strategy). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the ratio in pulmonary vascular resistance (PVR) at rest from baseline to Week 16 (time frame: From Baseline to Week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03809650.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.

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