CTIS2023-509305-68-00招募中1 期
A Study Evaluating the Long-term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE-Extension) - ROR-PH-303
nited Therapeutics Corp.0 个研究点目标入组 633 人开始时间: 2024年5月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 633
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •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., Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures., Completed the protocol-defined Study Drug Termination Visit or End of Study Visit procedures in the preceding ralinepag study., 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.
排除标准
- •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., Subjects who withdrew consent during participation in another ralinepag study., Female subjects who wish to become pregnant or who have a positive pregnancy test on Day 1 (OLE Entry Visit)., Women who are pregnant, lactating, or breastfeeding, 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., 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., Subjects who had an emergency unblinding procedure in a prior Phase 2 or 3 ralinepag study., Known hypersensitivity to ralinepag or any of the excipients., 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
相似试验
进行中（未招募）
1 期
An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertensioEUCTR2018-001189-40-BEnited Therapeutics Corporation1,000
进行中（未招募）
1 期
An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertensioEUCTR2018-001189-40-HRnited Therapeutics Corporation1,000
进行中（未招募）
1 期
An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertensioPulmonary arterial hypertension (PAH)MedDRA version: 20.0Level: LLTClassification code 10077731Term: Pulmonary hypertension WHO functional class ISystem Organ Class: 100000004855EUCTR2018-001189-40-PTnited Therapeutics Corporation1,000
进行中（未招募）
1 期
An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertensioPulmonary arterial hypertension (PAH)MedDRA version: 20.0Level: LLTClassification code 10077731Term: Pulmonary hypertension WHO functional class ISystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2018-001189-40-DKnited Therapeutics Corporation1,000
进行中（未招募）
1 期
An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ralinepag in patients with pulmonary arterial hypertensioPulmonary arterial hypertension (PAH)MedDRA version: 20.0Level: LLTClassification code 10077731Term: Pulmonary hypertension WHO functional class ISystem Organ Class: 100000004855EUCTR2018-001189-40-CZnited Therapeutics Corporation1,000