EUCTR2018-001189-40-PT进行中（未招募）1 期
A Study Evaluating the Long-term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE-Extension) - ADVANCE-extension
nited Therapeutics Corporation0 个研究点目标入组 1,000 人开始时间: 2019年3月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 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 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 (ie, 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.
- •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
排除标准
- •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 breastfeeding
- •5. Subjects who have undergone lung or heart/lung transplant or are
- •receiving longterm parenteral (intravenous [IV] or subcutaneous [SC]
- •infusion) or inhaled therapy with a prostacyclin or oral therapy with
- •another IP receptor agonist 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, eg, noncompliance
- •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.
研究者
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