A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option
Condition(s) studied
Investigational drug(s) / intervention(s)
Macitentan: Adult participants will receive oral dose of macitentan 10 milligrams (mg) tablet once daily. Children greater than or equal to (\>=) 2 year to less than (\<) 18 years will be given an oral macitentan dose tailored to their body weight, ensuring an equivalent level of systemic exposure as in adults.
Selexipag: Adult Participant will receive oral dose of selexipag tablet twice daily at the dose strength corresponding to their maintenance dose at the end of their parent study. Available strengths: 200, 400, 600, 800, 1000, 1200, 1400 and 1600 micrograms (µg). Children with body weight category of \>=50 kg will use the tablets at the required dose strength as described for adults. Children with a body weight \< 50 kg will receive tablets for pediatric use (dose strengths: 100 and 150 mcg), twice daily to enable continuation of individually maximum tolerated dose of selexipag according to their body weight category.
Macitentan/Tadalafil FDC: Participants will receive oral FDC of macitentan 10 mg and tadalafil 40 mg once daily during the course of the study as already received in the parent studies.
Study summary
The purpose of the study is to enable participants with pulmonary hypertension (PH) currently treated with study intervention(s) in a clinical study (parent studies \[NCT03422328, NCT03904693,NCT04565990, NCT02932410, NCT03492177, and NCT04175600\]), to continue to benefit from the intervention after closure of the parent study in case they have no alternative means of access to the study intervention. This study will allow assessment of the long-term safety of each study intervention.
Eligibility
Primary outcome measure(s)
- Frequency of Treatment Emergent Adverse Events (TEAEs) — Baseline until End of Study (EOS) (up to 84 months)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs are defined as a treatment-emergent AE is any AE temporally associated with the use of study treatment (from start of treatment in the PLATYPUS protocol until 30 days after study treatment discontinuation) whether or not considered by the investigator as related to study treatment. - Frequency of TEAEs Leading to Discontinuation — Baseline until EOS (up to 84 months)
Frequency of TEAEs leading to discontinuation of study intervention will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. TEAEs are defined as a treatment-emergent AE is any AE temporally associated with the use of study treatment (from start of treatment in the PLATYPUS protocol until 30 days after study treatment discontinuation) whether or not considered by the investigator as related to study treatment. - Frequency of Serious Adverse Events (SAEs) — Baseline until EOS (up to 84 months)
SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important. - Frequency of Deaths — Baseline until EOS (up to 84 months)
Frequency of deaths will be reported.
Trial sites (45)
| Facility | City | Region | Status |
|---|---|---|---|
| The Republican Scientific-Practical Center ''Cardiology'' | Minsk | Belarus | Recruiting |
| Minsk Regional Clinical Hospital Of The Red Banner Of Labor | Minsk | Belarus | Completed |
| UZ Leuven | Leuven | Belgium | Completed |
| University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD | Sofia | Bulgaria | Recruiting |
| Beijing Anzhen Hospital 1 | Beijing | China | Recruiting |
| Beijing Anzhen Hospital | Beijing | China | Recruiting |
| The Second Xiangya Hospital of Central South Hospital | Changsha | China | Recruiting |
| Jiangsu Province Hospital | Nanjing | China | Recruiting |
| Qingdao Women and Children's Hospital | Qingdao | China | Recruiting |
| Childrens Hospital of Shanghai | Shanghai | China | Recruiting |
| The First Affiliated Hospital of Xian Jiaotong University | Xi'an | China | Recruiting |
| Gottsegen György Országos Kardiológiai Intézet | Budapest | Hungary | Recruiting |
| Klinika Kardiologii Z Oddzialem Intensywnego Nadzoru Kardiologicznego UM W Bialymstoku | Bialystok | Poland | Recruiting |
| Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii | Bydgoszcz | Poland | Completed |
| SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im Prof Leszka Gieca | Katowice | Poland | Recruiting |
| Oddzial Kardiologii Wojewodzki Szpital Specjalistyczny im W Bieganskiego | Lodz | Poland | Completed |
| Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego SPZOZ | Lublin | Poland | Completed |
| SPSK2 PUM Klinika Kardiologii | Szczecin | Poland | Completed |
| Wojewodzki Szpital Specjalist Osrodek Badawczo Rozwojowy | Wroclaw | Poland | Completed |
| Wojewodzki Szpital Specjalistyczny we Wroclawiu | Wroclaw | Poland | Recruiting |
| Scientific and Research Institution of Cardiovascular Diseases Complex Problems | Kemerovo | Russia | Completed |
| E.Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation | Novosibirsk | Russia | Recruiting |
| Federal State Budgetary Institution | Saint Petersburg | Russia | Completed |
| Institute of Cardiology of Tomsk National Research Medical Center of Rus Academy of Sciences | Tomsk | Russia | Completed |
| Regional Clinical Hospital No1 | Tyumen | Russia | Recruiting |
| Abdullah, IA | Durban | South Africa | Completed |
| Dr Kalla | Lenasia | South Africa | Recruiting |
| Chungnam National University Hospital | Daejeon | South Korea | Recruiting |
| Gachon University Gil Medical Center | Incheon | South Korea | Recruiting |
| Seoul National University Hospital 1 | Seoul | South Korea | Recruiting |
| Seoul National University Hospital | Seoul | South Korea | Recruiting |
| Asan Medical Center | Seoul | South Korea | Recruiting |
| Samsung Medical Center | Seoul | South Korea | Recruiting |
| The Catholic University of Korea Seoul St Marys Hospital | Seoul | South Korea | Completed |
| Kaohsiung Veterans General Hospital | Kaohsiung City | Taiwan | Recruiting |
| National Cheng Kung University Hospital | Tainan | Taiwan | Recruiting |
| National Taiwan University Hospital | Taipei | Taiwan | Recruiting |
| Taipei Veterans General Hospital | Taipei | Taiwan | Recruiting |
| Chang-Gung Memorial Hospital, LinKou Branch | Taoyuan | Taiwan | Recruiting |
| Maharaj Nakorn Chiang Mai hospital Faculty of Medicine | Chiang Mai | Thailand | Recruiting |
+ 5 more sites — see the full list on the official registry below.
More Actelion trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05179876 on ClinicalTrials.gov ↗ ← All trials in China