Long-term study of ralinepag in people with pulmonary arterial hypertension
Continues ralinepag treatment in adults with pulmonary arterial hypertension who took part in earlier studies.
Plain-language title generated from the registry record
Registry title: A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
Key facts
- Where
- Bialystok, Poznan, and Wrocław, PolandSee the 3 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with WHO Group 1 pulmonary arterial hypertension (PAH) who finished an earlier ralinepag study and want to continue ralinepag.
- Age
- 18 years or older
- Sex
- Men and women can join.
- Disease stage
- WHO Group 1 pulmonary arterial hypertension (PAH).
- Earlier treatment
- Must have completed the final visits of an earlier ralinepag study. Must not have stopped that study early because of a drug-related side effect or tolerability problem.
Main reasons for not taking part
- Stopped the earlier ralinepag study early because of a drug-related side effect or tolerability problem
- Withdrew consent during another ralinepag study
- Wants to become pregnant, has a positive pregnancy test on Day 1, or is breastfeeding
- Had a lung or heart/lung transplant since the earlier ralinepag study
- Started long-term prostacyclin treatment by injection or inhalation since the earlier ralinepag study
Read by machine on 9 November 2026.
Where in Poland
- Uniwersytecki Szpital Kliniczny w BialymstokuBialystok, PolandNo longer taking part
- Uniwersytecki Szpital Kliniczny w PoznaniuPoznan, PolandNo longer taking part
- Premium Clinic Wrocław CMWrocław, PolandNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- United Therapeutics
- Trial code
- NCT03683186EU 2023-509305-68-00
- Record updated
- 6 October 2026
- Original description
Study ROR-PH-303, ADVANCE EXTENSION, is an open-label extension (OLE) study for participants with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag.Read full original descriptionShow less
A Phase 3 Open-label Extension (OLE) Study to Evaluate the Long-term Safety and Efficacy of Ralinepag in Subjects With World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH)
Study ROR-PH-303, ADVANCE EXTENSION, is an open-label extension (OLE) study for participants with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag.
Inclusion: Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures; Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures; Completed the protocol-defined Study Drug Termination Visit or End of Study Visit procedures in the preceding ralinepag study; Both male and female subjects agree to use a medically acceptable method of contraception throughout the entire study period from informed consent through the 30 day Follow-up Visit, if the possibility of conception exists. Eligible male and female subjects must also agree not to participate in a conception process (i.e., actively attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) during the study and for 30 days after the last dose of ralinepag.
Exclusion: Subjects who prematurely discontinued investigational medicinal product (IMP) due to a drug-related AE/SAE or tolerability issue in the preceding ralinepag study in which they were enrolled, or subjects who did not complete all protocol defined study procedures at a Study Drug Termination Visit or End of Study Visit in the preceding ralinepag study; Subjects who had an emergency unblinding procedure in a prior Phase 2 or 3 study; Subjects who have undergone lung or heart/lung transplant or the initiation of long-term parenteral or inhaled therapy with a prostacyclin during the time since participation in their original ralinepag study; Subjects who withdrew consent during participation in another ralinepag study; Female subjects who wish to become pregnant or who have a positive pregnancy test on Day 1 (OLE Entry Visit), or are lactating or breastfeeding.