A PHASE III OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY AND EFFICACY OF PRM-151 IN PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS (IPF) -

F. HOFFMANN - LA ROCHE LTD.0 个研究点目标入组 700 人开始时间: 2021年6月14日最近更新: 2021年8月17日

研究概览

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•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
•o Completed study treatment in Study WA42293 OR
•o 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

•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 including prolonged corrected QT interval > 450 ms (for men) or > 470 ms (for women) based on the Fridericia correction formula; or laboratory tests (hematology, serum chemistry, and urinalysis) that, in the opinion of the investigator, may pose an additional risk in administering study drug to the patient

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