An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy3

CB Biopharma SR0 个研究点目标入组 210 人开始时间: 2020年8月25日最近更新: 2020年11月9日

适应症

试验速览

暂无简介。

•-Study participant completed TP0003 [NCT04200456] or TP0006 [NCT04224688] until Visit 28 (Week 25) and, in the opinion of the investigator and sponsor, has been compliant with the TP0003 or TP0006 study assessments
•-The study participant is considered reliable and capable of adhering to the protocol, visit schedule, or medication intake according to the judgment of the investigator
•-If taking allowed concomitant medications, study participant must have been on stable doses
•- Study participants may be male or female:
•a) A male participant must agree to use contraception during the Treatment Period and for at least 3 months after the final dose of study treatment and refrain from donating sperm during this period
•b) A female participant is eligible to participate if she is not pregnant as confirmed by a negative urine pregnancy test or not planning to get pregnant during the breastfeeding, and at least one of the following conditions applies:
•Not a woman of childbearing potential (WOCBP)
•A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 3 months after the final dose of study treatment
•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 138
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 72

•-Study participant has any ongoing investigational medicinal product (IMP)-related serious adverse event (SAE) or ongoing severe IMP-related treatment-emergent adverse event (TEAE) experienced during TP0003 or TP0006
•-Study participant had any relevant resolved IMP-related SAE or severe IMP-related TEAE experienced during TP0003 or TP0006 that was not discussed and approved as acceptable for enrollment into open-label extension (OLE) study by Medical Monitor or designee
•-Study participant has, at last available assessment of TP0003 or TP0006, 3.0x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP)

发起方

CB Biopharma SR