A Prospective, Open-label, Platform Study for Long-term Follow-up of Participants Using Study Intervention in Pulmonary Hypertension Parent Studies

Who is this study for? Patients with pulmonary hypertension
What treatments are being studied? Macitentan+Selexipag+Tadalafil
Status: Recruiting
Location: See all (40) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 2
Healthy Volunteers: f
View:

• Participant must sign an informed consent form (ICF) (or their legally designated representative must sign) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study

• Participant treated with oral macitentan or selexipag or fixed dose combination (FDC) of macitentan 10 milligrams (mg) and tadalafil 40 mg at the end of a sponsor parent study and: a) the indication of the parent study is included in the intervention-specific appendices (ISA) (pulmonary arterial hypertension \[PAH\]; b) participant has completed the parent study; c) no alternative means of access to study intervention (or equivalent approved therapy) have been identified; d) participant may continue to benefit from treatment with the study intervention; e) Participant is at least 18 years old for macitentan/tadalafil FDC, and at least 2 years old for macitentan or selexipag

• A female participant of childbearing potential must: a) have a negative urine or serum pregnancy test prior to first intake of study intervention; b) agree to perform monthly urine pregnancy test up to the end of the safety follow-up period; c) If heterosexually active, agree to follow contraceptive methods until 30 days after the last intake of the study intervention. For pediatric female participants: It is the responsibility of the investigator to ensure appropriate counselling, including consultation with a specialist (if needed), to the participant and/or parent(s)/ legally designated representative (LDR)(s) on the acceptable method of contraception

Locations
Other Locations
Belarus
Minsk Regional Clinical Hospital Of The Red Banner Of Labor
RECRUITING
Minsk
The Republican Scientific-Practical Center ''Cardiology''
RECRUITING
Minsk
Belgium
UZ Leuven
COMPLETED
Leuven
Bulgaria
University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD
RECRUITING
Sofia
China
Beijing Anzhen Hospital
RECRUITING
Beijing
The Second Xiangya Hospital of Central South Hospital
RECRUITING
Changsha
Jiangsu Province Hospital
RECRUITING
Nanjing
Qingdao Women and Children's Hospital
RECRUITING
Qingdao
Childrens Hospital of Shanghai
RECRUITING
Shanghai
The First Affiliated Hospital of Xian Jiaotong University
RECRUITING
Xi'an
Hungary
Gottsegen György Országos Kardiológiai Intézet
RECRUITING
Budapest
Poland
Klinika Kardiologii Z Oddzialem Intensywnego Nadzoru Kardiologicznego UM W Bialymstoku
RECRUITING
Bialystok
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii
COMPLETED
Bydgoszcz
SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im Prof Leszka Gieca
RECRUITING
Katowice
Oddzial Kardiologii Wojewodzki Szpital Specjalistyczny im W Bieganskiego
RECRUITING
Lodz
Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego SPZOZ
RECRUITING
Lublin
SPSK2 PUM Klinika Kardiologii
RECRUITING
Szczecin
Wojewodzki Szpital Specjalist Osrodek Badawczo Rozwojowy
RECRUITING
Wroclaw
Wojewodzki Szpital Specjalistyczny we Wroclawiu
RECRUITING
Wroclaw
Republic of Korea
Chungnam National University Hospital
RECRUITING
Daejeon
Gachon University Gil Medical Center
RECRUITING
Incheon
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
The Catholic University of Korea Seoul St Marys Hospital
RECRUITING
Seoul
Russian Federation
Scientific and Research Institution of Cardiovascular Diseases Complex Problems
RECRUITING
Kemerovo
E.Meshalkin National Medical Research Center of the Ministry of Health of the Russian Federation
RECRUITING
Novosibirsk
Federal State Budgetary Institution
COMPLETED
Saint Petersburg
Institute of Cardiology of Tomsk National Research Medical Center of Rus Academy of Sciences
RECRUITING
Tomsk
Regional Clinical Hospital No1
RECRUITING
Tyumen
South Africa
Abdullah, IA
COMPLETED
Durban
Dr Kalla
RECRUITING
Lenasia
Taiwan
Kaohsiung Veterans General Hospital
RECRUITING
Kaohsiung City
National Cheng Kung University Hospital
RECRUITING
Tainan City
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Chang-Gung Memorial Hospital, LinKou Branch
RECRUITING
Taoyuan District
Thailand
Maharaj Nakorn Chiang Mai hospital Faculty of Medicine
RECRUITING
Chiang Mai
Ukraine
Municipal Inst. Of Dnipropetrovsk Region. Council
RECRUITING
Dnipro
State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine
COMPLETED
Kyiv
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2022-05-04
Estimated Completion Date: 2029-09-28
Participants
Target number of participants: 280
Treatments
Experimental: Macitentan
Participants who have completed a parent study, benefit from their study intervention maintenance and have no adequate alternative local treatment option will be enrolled in this study and will continue to receive study drug macitentan orally during the course of the study. For adult participants study visits will be scheduled every 6 months and for pediatric participants study visits will be scheduled every 3 months. The study includes on-site visits to collect efficacy and safety information until participant discontinuation/withdrawal, or the respective study intervention is made commercially available in the country/territory or an equivalent approved therapy becomes available, or the sponsor decides to terminate the study prematurely.
Experimental: Selexipag
Participants who have completed a parent study, benefit from their study intervention maintenance and have no adequate alternative local treatment option will be enrolled in this study and will continue to receive study drug selexipag orally during the course of the study. Study visits are scheduled every 6 months to collect efficacy and safety information until participant discontinuation/withdrawal, or the respective study intervention is made commercially available in the country/territory or an equivalent approved therapy becomes available, or the sponsor decides to terminate the study prematurely.
Experimental: Macitentan/Tadalafil FDC
Participants who have completed a parent study, benefit from their study intervention maintenance and have no adequate alternative local treatment option will be enrolled in this study and will continue to receive drug Macitentan and Tadalafil fixed dose combination (FDC) orally during the course of the study. Study visits are scheduled every 6 months to collect efficacy and safety information until participant discontinuation/withdrawal, or the respective study intervention is made commercially available in the country/territory or an equivalent approved therapy becomes available, or the sponsor decides to terminate the study prematurely.
Related Therapeutic Areas
Sponsors
Leads: Actelion

This content was sourced from clinicaltrials.gov