CTRI/2024/03/063705尚未招募3 期
An Extension Study to Evaluate the Long-term Safety of Rusfertide (PTG-300) in Subjects with Polycythemia Vera. - nil
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Subjects must meet ALL of the following inclusion criteria:
- •1. Subject who has completed at least 12 months of dosing with rusfertide and successfully completed the EOT visit of a previous Phase 2 or Phase 3 study of rusfertide.
- •2. 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
- •1. Subject who, in the opinion of the investigator, should not participate in the study.
- •2. Subject who discontinue early from a previous rusfertide study for reasons other than enrolling in this study.
- •3. Pregnant or lactating females.
- •4. 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 (See Appendix 2 for acceptable contraception methods).
- •5. 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 (See Appendix 2 for acceptable contraception methods).
- •6. 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.
- •7. 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.
- •8. 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.
- •9. Plan to use investigational treatment other than rusfertide during the course of the study or within 28 days after last rusfertide dose.
- •10. Subject with hypersensitivity to rusfertide or to any of the excipients.
- •11. In the investigator’s opinion the subject has progressive disease that cannot be managed by adjusting concurrent cytoreductive therapy.
研究者
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