CompletedPhase 2

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

Belgium, China, Czechia76 participantsStarted 2015-02-03

Plain-language 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)

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)

Number of Participants With AEs Leading to Study Drug Discontinuation

Timeframe: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)

Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)

Timeframe: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)

Number of Participants With Hemoglobin Abnormalities

Timeframe: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)

Number of Participants With Liver Tests Abnormalities

Timeframe: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)

Change From Baseline in Blood Pressure at Month 6

Timeframe: Baseline and Month 6

Trial details

NCT IDNCT02060721

SponsorActelion

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-03-21

Results submitted2023-03-17

View on ClinicalTrials.gov More Chronic Thromboembolic Pulmonary Hypertension trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)

Number of Participants With AEs Leading to Study Drug Discontinuation

Timeframe: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)

Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)

Timeframe: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)

Number of Participants With Hemoglobin Abnormalities

Timeframe: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)

Number of Participants With Liver Tests Abnormalities

Timeframe: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)

Change From Baseline in Blood Pressure at Month 6

Timeframe: Baseline and Month 6