EUCTR2018-001189-40-BE进行中（未招募）1 期
A Study Evaluating the Long-term Efficacy and Safety of Ralinepag inSubjects 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: 2018年12月10日最近更新:
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 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.
- •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 breast-feeding
- •5. Subjects who have undergone lung or heart/lung transplant or are receiving longterm parenteral (intravenous [i.v.] infusion or subcutaneous injection) 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, 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.
研究者
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