An Extension Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects With Polycythemia Vera (THRIVE)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Hematocrit
研究概览
简要总结
The goal of this clinical trial is to assess long-term safety and efficacy of rusfertide in subjects with polycythemia vera. Subjects who complete dosing with rusfertide until the end-of-treatment visit of a Phase 2 rusfertide study and meet the inclusion/exclusion criteria for this study, are eligible to participate in this open-label study and continue treatment with rusfertide.
详细描述
This is an open-label study designed to assess the long-term safety and efficacy of rusfertide. This study aims to provide long-term rusfertide treatment to subjects who complete dosing until the end-of-treatment of a previous Phase 2 rusfertide study and are likely to continue benefiting from treatment with rusfertide based on their improved control of hematocrit levels <45% and reduced need for therapeutic phlebotomies. This study will provide long-term rusfertide treatment to these subjects and obtain data on safety and efficacy of long-term treatment with rusfertide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject who has completed at least 12 months of dosing with rusfertide and successfully completed the end of treatment visit of a previous Phase 2 study of rusfertide.
- •Subject understands the study procedures, is willing and able to adhere to study requirements and agrees to participate in the study by giving written informed consent.
排除标准
- •Subject who, in the opinion of the investigator, should not participate in the study.
- •Subject who discontinue early from a previous rusfertide study for reasons other than enrolling in this study.
- •Pregnant or lactating females.
- •Women of childbearing potential (WOCBP) who do not agree to use medically acceptable contraception (<1% annual failure rate) during the study and for 30 days after the last dose of study drug.
- •Men with partners of childbearing potential who do not agree to use medically acceptable contraception (<1% annual failure rate) during the study and for 90 days after the last dose of study drug.
- •Men who do not agree to use a condom during the study and for 90 days after the last dose of study drug regardless of the partner's childbearing potential.
- •A female subject intends to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 30 days after receiving the last dose of study drug.
- •A male subject intends to donate sperm for the purpose of reproduction during the study and for a minimum of 90 days after receiving the last dose of study drug.
- •Plan to use investigational treatment other than rusfertide during the course of the study or within 28 days after last rusfertide dose.
- •Subject with hypersensitivity to rusfertide or to any of the excipients.
- •In the investigator's opinion the subject has progressive disease that cannot be managed by adjusting concurrent cytoreductive therapy.
研究组 & 干预措施
Open-label rusfertide
Open-label rusfertide
干预措施: Open-label rusfertide (Drug)
结局指标
主要结局
Hematocrit
时间窗: 0-2 years
Median hematocrit
Phlebotomies
时间窗: 0-2 years
Number of phlebotomies
次要结局
未报告次要终点