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
- Genoa, Palermo, Pavia, and Rome, ItalySee the 4 sites
- Phase
- Phase 3
Where in Italy
- IRCCS Ospedale Policlinico San MartinoGenoa, ItalyNo longer taking part
- Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione S.r.l. I.S.M.E.T.T. S.r.l.Palermo, ItalyNo longer taking part
- Fondazione IRCCS Policlinico San MatteoPavia, ItalyNo longer taking part
- Azienda Ospedaliero-Universitaria Policlinico Umberto IRome, ItalyNo 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.