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Could a new dose of selexipag help kids with rare lung disease?

NCT ID NCT03492177

Disease control Sponsor: Actelion Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This study is testing the safety and right dose of a drug called selexipag in children aged 2 to 17 with pulmonary arterial hypertension (PAH), a serious condition where blood pressure in the lungs is too high. The goal is to find a dose that works like the adult version. The study involves 63 children and is currently active but not recruiting new participants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

63 people

The number who actually took part.

Started

Jul 2018

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Signed and dated informed consent by the parent(s) or Legally authorized representative(s) AND assent from developmentally capable children * Males or females between greater than or equal to (\>=) 2 and less than (\<) 18 years of age with weight \>= 9 kilograms (kg) * Pulmonary arterial hypertension (PAH) diagnosis confirmed by documented historical right heart catheterization (RHC) performed at any time before participant's enrollment * PAH with one of the following etiologies: * idiopathic (iPAH), * heritable (hPAH), * associated with congenital heart disease (CHD): PAH with co-incidental CHD; post-operative PAH (persisting/ recurring/ developing \>= 6 months after repair of CHD) * Drug or toxin-induced * PAH associated with HIV * PAH associated with connective tissue disease * Word Health Organization functional class (WHO FC) II to III * Participants treated with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor provided that the treatment dose(s) has been stable for at least 3 months prior to enrollment, or participants who are not candidates for these therapies * Females of childbearing potential must have a negative pregnancy test at Screening and at Enrollment, and must agree to undertake monthly pregnancy tests, and to use a reliable method of contraception (if sexually active) from screening up to study drug discontinuation plus 30 days (EOS) Key Exclusion Criteria: * Participants with PAH due to portal hypertension, schistosomiasis, pulmonary veno-occlusive disease (PVOD) and/or pulmonary capillary hemangiomatosis * Participants with PAH associated with Eisenmenger syndrome * Participants with moderate to large left-to-right shunts * Participants with cyanotic congenital cardiac lesions such as transposition of the great arteries, truncus arteriosus, univentricular heart or pulmonary atresia with ventricular septal defect, as well as Participants with Fontan-palliation * Participants with pulmonary hypertension due to lung disease * Previous treatment with Uptravi (selexipag) within 2 weeks prior to enrollment * Participants having received prostacyclin (epoprostenol) or prostacyclin analogs (that is, treprostinil, iloprost, beraprost) within 2 months prior to enrollment or are scheduled to receive any of these compounds during the trial * Treatment with another investigational drug within 4 weeks prior to enrollment * History, or current suspicion of intussusception or ileus or gastrointestinal obstruction as per investigator's judgment * Uncontrolled thyroid disease as per investigator judgment * Hemoglobin or hematocrit \< 75 percentage (%) of the lower limit of normal range * Known severe or moderate hepatic impairment * Clinical signs of hypotension that in the investigator's judgment would preclude initiation of a PAH-specific therapy * Participants with severe renal insufficiency * Known hypersensitivity to the investigational treatment or to any of the excipients of the drug formulations

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Conditions

The condition(s) this trial relates to.

pulmonary arterial hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary arterial hypertension

Contacts and locations

Locations

  • Almazov National Medical Research Center Of The Ministry Of Health Of The Russian Federation

    Saint Petersburg, 197341, Russia

  • Beijing Anzhen Hospital

    Beijing, 100029, China

  • CHU Arnaud de Villeneuve

    Montpellier, 34295, France

  • Centre Hospitalier Sainte Justine

    Montreal, Quebec, H3T 1C4, Canada

  • Children'S Hospital Cardiac Care Center University Of Colorado

    Aurora, Colorado, 80045, United States

  • Chu Hopital Des Enfants

    Toulouse, 31059, France

  • Gottsegen Gyorgy Orszagos Kardiologiai Intezet, Felnott kardiologiai osztaly

    Budapest, 1096, Hungary

  • Great Ormond Street Hospital

    London, WC1N 3JH, United Kingdom

  • Health Institution 4Th City Children'S Clinical Hospital

    Minsk, 220118, Belarus

  • Hôpital Necker - Enfants Malades

    Paris, 75015, France

  • Institut Jantung Negara (National Heart Institute)

    Kuala Lumpur, 50400, Malaysia

  • Institut Za Zdravstvenu Zastitu Majke I Deteta Srbije Dr Vukan Cupic

    Belgrade, 11070, Serbia

  • Kazan State Medical University

    Kazan', 420059, Russia

  • Lviv Regional Clinical Hospital

    Lviv, 79010, Ukraine

  • Moscow Scientific Research Institute For Pediatrics And Childrens Surgery Of Rosmedtechnologies

    Moscow, 125412, Russia

  • Municipal Enterprise Of The Dnipropetrovsk Regional Council

    Dnipro, 49070, Ukraine

  • Municipal Institution Of The Zaporizhzhya Regional Council

    Zaporizhzhya, 69063, Ukraine

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • Saint Petersburg State Pediatric Medical University

    Saint Petersburg, 194100, Russia

  • Samara Regional Clinical Cardiological Dispensary

    Samara, 443070, Russia

  • Sarawak Heart Center

    Kota Samarahan, 94300, Malaysia

  • Schneider Children's Medical Center

    Petach Tikvah, Israel

  • Scientific and Research Institution of Cardiovascular Diseases Complex Problems

    Kemerovo, 650002, Russia

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

  • Shanghai Childrens Medical Center

    Shanghai, 200127, China

  • Sheba Medical Center

    Ramat Gan, 52621, Israel

  • State Institution Of The Ministry Of Health Of Ukraine

    Kiev, 04050, Ukraine

  • State Institution Republican Scientific And Practical Center For Pediatric Surgery

    Minsk, 220013, Belarus

  • UZ Gent

    Ghent, 9000, Belgium

  • University of Iowa Hospital

    Iowa City, Iowa, 52242, United States

  • Universitätsklinikum Freiburg Zentrum

    Freiburg im Breisgau, 70106, Germany

  • Univerzitetska Dečja Klinika

    Belgrade, 11000, Serbia

  • Wojewodzki Szpital Specjalistyczny We Wroclawiu

    Wroclaw, 51 124, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.