EUCTR2018-001189-40-HR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6月5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 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. This criterion is not applicable starting with Protocol Amendment 3.
- •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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