NCT03492177Active, not recruitingPhase 2
A Clinical Study of to Confirm the Doses of Selexipag in Children With Pulmonary Arterial Hypertension
A Prospective, Multicenter, Open Label, Single Arm, Phase 2 Study to Investigate the Safety, Tolerability and Pharmacokinetics of Selexipag in Children With Pulmonary Arterial Hypertension
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
The purpose of this study to confirm the selexipag starting dose(s), selected based on pharmacokinetic (PK) extrapolation from adults, that leads to similar exposure as adults doses in children from greater than or equal to (\>=) 2 to less than (˂) 18 years of age with Pulmonary Arterial Hypertension (PAH), by investigating the PK of selexipag and its active metabolite ACT-333679 in this population.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 63 (actual)
- First submitted
- 3 Apr 2018
- Start date
- 23 Jul 2018
- Primary completion date
- 28 Mar 2022
- Lead sponsor
- Actelion
- NCT number
- NCT03492177
- EU CT number
- 2022-503042-42-00
- EudraCT number
- 2018-000145-39
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 63
- From 23 Jul 2018 to the primary completion date, 28 Mar 2022
- 33 sites in 16 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Clinical signs of hypotension that in the investigator's judgment would preclude initiation of a PAH-specific therapy
Other illness
- 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 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
- Uncontrolled thyroid disease as per investigator judgment
- Known severe or moderate hepatic impairment
- Participants with severe renal insufficiency
- Known hypersensitivity to the investigational treatment or to any of the excipients of the drug formulations
Lab values
- Hemoglobin or hematocrit \< 75 percentage (%) of the lower limit of normal range
Other
- Participants with moderate to large left-to-right shunts
- History, or current suspicion of intussusception or ileus or gastrointestinal obstruction as per investigator's judgment
Who the study is looking for
- 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)
Age in the registry: 2 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (33)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Gent Coordinator of this site? Confirm its status | Ghent | Belgium | Unknown status |
| State Institution Republican Scientific And Practical Center For Pediatric Surgery Coordinator of this site? Confirm its status | Minsk | Belarus | Unknown status |
| Health Institution 4Th City Children'S Clinical Hospital Coordinator of this site? Confirm its status | Minsk | Belarus | Unknown status |
| Centre Hospitalier Sainte Justine Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Beijing Anzhen Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Shanghai Childrens Medical Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Active, not recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Hopital Des Enfants Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Active, not recruiting |
| Great Ormond Street Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Gottsegen National Cardiovascular Center Coordinator of this site? Confirm its status | Budapest | Hungary | Active, not recruiting |
| Schneider Children's Medical Center Coordinator of this site? Confirm its status | Petach Tikvah | Israel | Unknown status |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Sarawak Heart Center Coordinator of this site? Confirm its status | Kota Samarahan | Malaysia | Unknown status |
| Institut Jantung Negara - National Heart Institute Coordinator of this site? Confirm its status | Kuala Lumpur | Malaysia | Unknown status |
| Wojewodzki Szpital Specjalistyczny We Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
| Institut za Zdravstvenu Zastitu Majke i Deteta Srbije Dr Vukan Cupic Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Univerzitetska Dečja Klinika Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Kazan State Medical University Coordinator of this site? Confirm its status | Kazan' | Russia | Unknown status |
| Scientific and Research Institution of Cardiovascular Diseases Complex Problems Coordinator of this site? Confirm its status | Kemerovo | Russia | Unknown status |
| Moscow Scientific Research Institute For Pediatrics And Childrens Surgery Of Rosmedtechnologies Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Saint Petersburg State Pediatric Medical University Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Almazov National Medical Research Center of the Ministry of Health of the Russian Federation Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Samara Regional Clinical Cardiological Dispensary Coordinator of this site? Confirm its status | Samara | Russia | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Municipal Enterprise Of The Dnipropetrovsk Regional Council Coordinator of this site? Confirm its status | Dnipro | Ukraine | Unknown status |
| State Institution Of The Ministry Of Health Of Ukraine Coordinator of this site? Confirm its status | Kiev | Ukraine | Unknown status |
| Lviv Regional Clinical Hospital Coordinator of this site? Confirm its status | Lviv | Ukraine | Unknown status |
| Municipal Institution Of The Zaporizhzhya Regional Council Coordinator of this site? Confirm its status | Zaporizhzhya | Ukraine | Unknown status |
| Children'S Hospital Cardiac Care Center University Of Colorado Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| University of Iowa Hospital Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| Seattle Children's Hospital Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.