NCT04767802已完成2 期
A Phase 2 Study of the Hepcidin Mimetic PTG-300 in Patients With Polycythemia Vera and Elevated Hematocrit (PACIFIC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 8
- 主要终点
- Evaluate PTG-300's efficacy in subjects with PV and baseline elevated hematocrit.
研究概览
简要总结
This is an open label, single arm trial of PTG-300 in subjects with PV who are newly diagnosed or for whom current therapy is not sufficient to control their hematocrit and have hematocrit >48% prior to dosing. The PTG-300 dose and schedule may be adjusted every 2 to 4 weeks to maintain hematocrit <45% with a target of <43%. Subjects may receive PTG-300 treatment for up to 52 weeks.
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
- •Known diagnosis of polycythemia vera.
- •Hematocrit >48% before dosing.
- •Evidence of hematocrit >48% three or more times in the 28 weeks before dosing or five or more times in 52 weeks before dosing (except for newly diagnosed patients).
- •Clinically reasonable alternative causes for erythrocytosis have been evaluated and excluded.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
排除标准
- •Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) within 3 months of Screening.
- •Active or chronic bleeding within 4 weeks of Screening.
- •Meets the criteria for post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT).
- •Infection requiring hospitalization or intravenous antimicrobial therapy, or opportunistic infection within 3 months of dosing; any infection requiring systemic antimicrobial therapy within 4 weeks of dosing. Prophylactic antibiotics are allowed.
- •Any serious or unstable medical or psychiatric condition that would prevent, (as judged by the Investigator) the subject from properly providing informed consent or any condition which would jeopardize compliance with the study.
- •Known primary or secondary immunodeficiency.
- •Known positive for active hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
- •Any surgical procedure requiring general anesthesia within 1 month prior to Screening or planned elective surgery during the study.
- •History of invasive malignancies within the last 2 years, except non-melanoma skin cancer and localized curatively treated prostate cancer or cervical cancer.
- •Current or recent history of alcohol dependence or illicit drug use within 1 year prior to Screening.
研究组 & 干预措施
PTG-300
Experimental
Evaluate PTG-300's efficacy and safety in subjects with PV and baseline elevated hematocrit.
干预措施: PTG-300 (Drug)
结局指标
主要结局
Evaluate PTG-300's efficacy in subjects with PV and baseline elevated hematocrit.
时间窗: Estimate the proportion of subject with a hematocrit less than 45% at Week 16
Proportion of subjects with hematocrit \<45%
次要结局
- Safety of PTG-300(Week 52)
研究者
研究点 (8)
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