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An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertensio

Phase 1
Conditions
MedDRA version: 20.0Level: LLTClassification code 10077731Term: Pulmonary hypertension WHO functional class ISystem Organ Class: 100000004855
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Pulmonary arterial hypertension (PAH)
Registration Number
EUCTR2018-001189-40-GB
Lead Sponsor
nited Therapeutics Corporation
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
1000
Inclusion Criteria

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 EOS procedures and EOS Visit in the original 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 IMP. Highly effective birth control methods include the following:
• oral, implantable, or injectable contraceptives associated with the inhibition of ovulation (starting =60 days before dosing) in combination with a diaphragm with vaginal spermicide, cervical cap with vaginal spermicide, or male condom;
• standard intrauterine device (IUD; e.g., Copper T 380A IUD), intrauterine system (IUS; e.g., LNg 20 IUS - progesterone IUD), progesterone implant, or tubal sterilization (=180 days after surgery);
• post vasectomy and male condom, partner using diaphragm with spermicide, cervical cap with spermicide, estrogen and progesterone oral contraceptives (the pill”), estrogen and progesterone transdermal patch, vaginal ring, or progesterone injection.
• Complete sexual abstinence defined as refraining from heterosexual intercourse for the entire period of risk associated with study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the usual lifestyle of the subject. Periodic abstinence (calendar, symptothermal, post-ovulation methods) is not acceptable.
Women who surgically sterile or are postmenopausal (defined as: 12 consecutive months with no menses without an alternative medical cause) are not considered to be of childbearing potential. If of childbearing potential, female partners of male study participants should agree to utilize medically acceptable methods of contraception for the duration of study participation.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

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 original ralinepag study in which they were enrolled, or subjects who did not complete all protocol defined study procedures at an EOS Visit (not Early Termination Visit) in the original 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 the initiation of parenteral (intravenous [i.v.] infusion or subcutaneous injection) 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 study or subjects who developed withdrawal criteria in their original study but were not withdrawn.
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 clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
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