EUCTR2020-001429-30-NL进行中（未招募）1 期
A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 658
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
- •Taken part in a previous study of PRM-151, as follows:
- •o Participated in Study PRM-151-202, and tolerated the study drug in the opinion of the investigator OR Completed study treatment in Study WA42293 OR Participated in Study WA42293 but have discontinued from study treatment
- •For women of childbearing potential: agreement to remain abstinent or use contraception, women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 8 weeks after the final dose of PRM-151
- •For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm, with a female partner of childbearing potential or pregnant female partner, men must remain abstinent or use a condom during the treatment period and for 8 weeks after the final dose of PRM-151 to avoid exposing the embryo. Men must refrain from donating sperm during this same period
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 500
排除标准
- •? Received any experimental treatment other than PRM-151 within 4 weeks or five half-lives of the experimental drug, whichever is longer, prior to the first dose in the OLE study
- •? Receiving strong inhibitor or inducer of CYP1A2 in patients taking pirfenidone
- •? Receiving potent inhibitor or inducer of P-gp in patients taking nintedanib
- •? Acute respiratory or systemic bacterial, viral, or fungal infection at the first visit of the OLE, or within 2 weeks of the first visit for patients joining Cohort A (from Study PRM-151-202)
- •? History of smoking within 3 months prior to the first visit in the OLE
- •? History of alcohol or substance use disorder within 2 years prior to the first visit of the OLE or known or suspected active alcohol or substance-use disorder
- •? History of severe allergic reaction or anaphylactic reaction to PRM-151
- •? Clinically significant abnormality on ECG during eligibility assessment that, in the opinion of the investigator, may pose an additional risk in administering study drug to the patient.
- •? Prolonged corrected QT interval > 450 ms (for men) or > 470 ms (for women) based on the Fridericia correction formula.
- •? Clinically significant laboratory test abnormalities (hematology, serum chemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the patient.
- •? Any of the following laboratory abnormalities known at the time of the first visit
- •– ALT and/or AST >= 2.5 x upper limit of normal (ULN)
- •– Total bilirubin >= 2xULN
- •? Pregnant or breastfeeding, or intending to become pregnant during the study (for Cohort A or B patients).
研究者
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