EUCTR2021-002452-37-IT进行中（未招募）1 期
A Multi-Center, Open Label, Extension Study Evaluating the Safety and Efficacy of Bomedemstat for the Treatment of Patients with Myeloproliferative Neoplasms (MPNs) Enrolled in a Prior BomedemstatClinical Study. - IMG-7289-CTP-202 Phase 2 Myeloproliferative Neoplasms Study
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients must meet all of criteria to be eligible for study enrollment:
- •1. Completed at least one Treatment Period (TP) in a prior bomedemstat MPN protocol (such as, but not limited to, IMG-7289-CTP-102 or IMG-7289-CTP-201).
- •2. In the estimation of the Investigator, the risk-benefit favors continued dosing with bomedemstat.
- •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 28
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 52
排除标准
- •Patients will be excluded from the study if they meet any of the
- •following criteria:
- •1. Ongoing participation in another investigational study (except observational studies).
- •2. A history of non-compliance in a prior bomedemstat study (excluding dose suspensions that were medically warranted).
- •3. Current use of a prohibited medication (e.g., romiplostim).
- •4. Medical, psychiatric, cognitive, or other conditions that, in the Investigator's opinion, compromise the patient's safety, ability to give informed consent, or comply with the trial protocol.
- •5. Females who are pregnant or breastfeeding or plan to become pregnant or breastfeed during the study.
- •6. Women of childbearing potential (WOCBP) and fertile men (see Section 6.1) unwilling to agree to use an approved method of contraception from time of enrollment until 14 days* after last
- •bomedemstat dose. Methods of contraception include: estrogen and progestogen combined hormonal contraception which inhibits ovulation; progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device (IUD); bilateral tubal occlusion; vasectomized partner in a monogamous sexual relationship (vasectomy or tubal ligation at least six months prior to dosing); and, complete sexual abstinence (defined as refraining from heterosexual intercourse).
- •Patients practicing abstinence must agree to use an approved method of contraception if they become sexually active during the study.
研究者
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