NL-OMON50371已完成3 期
An Open-Label Extension Study of UT-15C in Subjects with Pulmonary Arterial Hypertension - A Long-Term Follow-Up to Protocol TDE-PH-310 - Open-label study of UT-15C in PAH patients
nited Therapeutics Corp0 个研究点目标入组 4 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4
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 99（—）
入选标准
- •1. The subject voluntarily provides informed consent to participate in the
- •2. The subject participated in study TDE-PH-310 and met the definition of
- •clinical worsening (as specified in Protocol TDE PH 310), remained on study
- •drug, was compliant with study procedures and assessments during the TDE-PH-310
- •Study or was currently enrolled in that study at the time the study was
- •discontinued by the sponsor.
- •3. All WOCBP must practice true abstinence from intercourse when it is in line
- •with their preferred and usual lifestyle, or use 2 different forms of highly
- •effective contraception for the duration of the study, and for at least 30 days
- •after discontinuing study medication. Medically acceptable forms of effective
- •contraception include: (1) approved hormonal contraceptives (such as birth
- •control pills), (2) barrier methods (such as a condom or diaphragm) used with a
- •spermicide, (3) an intrauterine device or (4) partner vasectomy. For women of
- •childbearing potential, a negative urine pregnancy test is required at Baseline
- •(study entry) prior to initiating study medication. WOCBP includes any female
- •who has experienced menarche and who has not undergone successful surgical
- •sterilization (hysterectomy, bilateral tubal ligation, or bilateral
- •oophorectomy) or is not postmenopausal [defined as amenorrhea for at least 12
- •consecutive months].
- •4. Males participating in the study must use a condom during the length of the
- •study, and for at least 48 hours after their last dose of study medication.
排除标准
- •1. The subject is pregnant or lactating.
- •2. The subject has received infused or inhaled prostacyclin therapy for 29 days
- •3. The subject was prematurely discontinued from study TDE-PH-310 for reasons
- •other than a clinical worsening event.
- •4. The subject developed a concurrent illness or condition during the conduct
- •of TDE PH 310 which, in the opinion of the Investigator, would represent a risk
- •to overall health if they enrolled in this study.
研究者
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