A Study Evaluating the Long-term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE Extension)
- Conditions
- high lung blood pressurepulmonary arterial hypertension (PAH)10037454
- Registration Number
- NL-OMON49858
- Lead Sponsor
- nited Therapeutics Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 4
Each subject must meet ALL of the following inclusion criteria to be eligible
for enrollment into the study:
1. Evidence of a personally signed and dated informed consent document
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 highly effective method of
birth control 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.
Eligible subjects must not meet ANY of the following exclusion criteria to be
eligible for enrollment into the study:
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).
4. Women who are pregnant, lactating or breast-feeding
5. Subjects who have undergone lung or heart/lung transplant or are receiving
longterm parenteral (intravenous [i.v.] infusion or subcutaneous infusion) or
inhaled therapy with a prostacyclin or oral therapy with another IP receptor
agonist (selexipag) during the time since participation in their original
ralinepag study.
6. Male subjects with a corrected QT interval using Fridericia's formula (QTcF)
>450 msec and female subjects with QTcF > 470 msec on electrocardiogram (ECG)
recorded within 12 weeks prior to Day 1.
7. Subjects who had an emergency unblinding procedure in a prior Phase 2 or 3
ralinepag study.
8. Known hypersensitivity to ralinepag or any of the excipients.
9. Any reason that, in the opinion of the investigator or medical monitor,
precludes the subject from participating in the study, e.g., non-compliance
concerns, any previous or intercurrent medical condition that may increase the
risk associated with study participation or that would confound study analysis
or impair study participation or cooperation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Efficacy assessments will include an evaluation of:<br /><br>• N-terminal pro b-type natriuretic peptide (NT-proBNP)<br /><br>• 6-minute walk distance (6MWD)<br /><br>• WHO/NYHA functional class<br /><br>• The proportion of subjects who achieve all 3 of the following (at<br /><br>specified time points):<br /><br>* NT-proBNP level <300 pg/mL<br /><br>* 6MWD >440 meters<br /><br>* WHO/NYHA FC II status or better<br /><br>• HRQoL measures (where validated)<br /><br>• Time to all-cause hospitalization during the study period<br /><br>• Time to all-cause mortality during the study period</p><br>
- Secondary Outcome Measures
Name Time Method <p>N/A</p><br>