CLINICAL TRIAL / NCT03683186
A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
- Interventional
- Recruiting
- NCT03683186
Contact Information
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.
Study ROR-PH-303 is a multicenter, open-label extension (OLE) study for subjects with WHO
Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag and who
qualify for entry based upon participation in the prior study. Subjects who discontinue
participation in a prior study due to safety issues related to study medication or who fail
to complete study procedures will not be eligible to enter Study ROR-PH-303. Subjects who
meet all OLE entry criteria will be enrolled and will receive ralinepag in addition to their
pre-existing PAH disease-specific background therapy.
For subjects who are enrolled from an ongoing double-blind Phase 2 or Phase 3 ralinepag
study, a 16-week blinded Dose Titration Period will be completed following enrollment into
the OLE. Subjects previously on ralinepag will continue on the same dose during the Dose
Titration Period as received in the original study and will also initiate placebo treatment
in the OLE.
Subjects who are enrolled from a non-blinded study or another OLE will not participate in the
blinded Dose Titration Period in Study ROR-PH-303 but will be enrolled directly into the
Treatment Period and continue on the dose of ralinepag received in the original study.
All subjects will receive ralinepag in the OLE study until premature discontinuation of
ralinepag due to an AE/serious adverse event (SAE) or other reason, marketing approval of
ralinepag is granted in the region in which the study is conducted, or the study is
discontinued by the Sponsor.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
Inclusion Criteria:
1. 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.
2. Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.
3. Completed the protocol-defined Study Drug Termination Visit or End of Study Visit
procedures in the preceding ralinepag study.
4. 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 Criteria:
1. 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.
2. Subjects who withdrew consent during participation in another ralinepag study.
3. 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.
4. 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.
5. Subjects who had an emergency unblinding procedure in a prior Phase 2 or 3 study.
- Connective Tissue Diseases
- Hypertension
- Lung Disease
- Lung Diseases
- Pulmonary Arterial Hypertension
- Pulmonary Hypertension