An Open Label Extension Study of PTG-300 in Non-Transfusion Dependent (NTD) and Transfusion-Dependent (TD) ß-thalassemia Subjects

Protagonist Therapeutics, Inc.0 个研究点目标入组 84 人开始时间: 2019年10月17日最近更新: 2020年7月13日

研究概览

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•1.NTD and TD ß-thalassemia subjects who completed Week 12 and Week 16 respectively in Study PTG-300-02.
•2.Women of childbearing potential (WOCBP) and men agree to use a highly effective contraceptive measure (base on the Clinical Trial Facilitation Group [CTFG]) during the duration of the study and for 4 weeks after the last dose of study drug in the case of women and 90 days after the last dose of study drug in the case of men.
•3.For WOCBP, a negative urine pregnancy test within 24 hours prior to the first dose of study medication in this study.
•4.Subjects or legal guardians (in the case of minors) understand the study procedures and agree to participate in the study by giving written informed consent.
•5.Subjects, or legal representative (in the case of minors) are willing and able to adhere to the study visit schedule and other protocol requirements.
•6.Subjects between 12-<18 years of age understand and provide the assent to participate in the study, according to local guidelines.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 24
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 60
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Subjects who discontinued prematurely from study 300-02 (before Week 12 in NTD and Week 16 in TD)
•2.Clinically meaningful laboratory abnormalities at Screening.
•3.Pregnant or lactating females.
•4.Current history of alcohol dependence or illicit drug use.
•5.Subject has a concurrent clinically significant, unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic or other medical disorder that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the subject by their participation in the study.
•6.Subject is mentally or legally incapacitated at the time of Screening visit or has a history of clinically significant psychiatric disorders that would impact the subject’s ability to participate in the trial according to the Investigator.
•7.Concurrent participation in any other interventional study.

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