Safety & Pharmacokinetics of Pegolsihematide for Treatment of Anemia Patient With Myelodysplastic Syndromes

Jiangsu Hansoh Pharmaceutical Co., Ltd.1 个研究点分布在 1 个国家目标入组 24 人开始时间: 2014年6月最近更新: 2015年12月2日

适应症

干预措施

试验速览

阶段: 1 期
发起方
入组人数: 24
试验地点: 1
主要终点: Area Under the Curve [AUC]).

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The primary objectives of the trial are to assess the safety and pharmacokinetics profile of pegolsihematide for treatment of anemia patient with myelodysplastic syndromes.

详细描述

The study started from the lowest dose, 0.08mg/kg, each group will enroll 4 to 6 subjects.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
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

•Men or women ≥18 years, premenopausal women must have negative pregnancy test.
•Documented diagnosis of myelodysplastic syndromes (MDS) according to World Health Organization (WHO) criteria, including refractory anemia (RA), refractory anemia with ringed sideroblasts (RARS), refractory cytopenia with multilineage dysplasia (RCMD), MDS-U, 5q-.
•Meets International Prognostic Scoring System (IPSS) classification of low or intermediate-1 risk disease as determined by microscopic and standard cytogenetic analysis of the bone marrow during screening.
•Never with erythropoietin agents treatment prior to enrollment.
•Eastern cooperative oncology group (ECOG) performance status of 0 or 1 during screening.
•Hemoglobin ≥7g/dL and ≤10g/dL, at least two detections during screening.
•Adequate transferrin saturation (≥15%), ferritin (≥12ng/mL), folate (≥ lower limits of normal), vitamin B12 (≥ lower limits of normal)
•Patients understand and are able to provide written informed consent.

排除标准

•Pregnant or breast feeding women or women having positive pregnant test, women or men whose spouse plan to become pregnant with 4 weeks after the end of treatment .
•Therapy-related or secondary MDS.
•Previously diagnosed with intermediate-2 or high risk MDS per International Prognostic Scoring System (IPSS).
•History of severe allergic or anaphylactic reactions or hypersensitivity to erythropoiesis-stimulating agents or polyethylene glycol.
•History of red blood cell or blood transfusion during 4 weeks prior to enrollment.
•Known other disease which can lead to anemia (including haemolytic disease and digestive tract hemorrhage).
•Uncontrolled hypertension 2 weeks prior to enrollment, defined as systolic blood pressure ≥160mmHg or diastolic blood pressure ≥ 95mmHg.
•Clinically significant systemic infection or uncontrolled chronic inflammatory disease (ie, rheumatoid arthritis, inflammatory bowel disease) as determined by the investigator at screening.
•Evidence of bone marrow collagen fibrosis, biopsy argentaffin staining showed reticular fiber ≥＋＋.
•History of deep venous thrombosis or arterial embolism within 12 months prior to enrollment.
•History of cardiocerebrovascular events within 6 months prior to enrollment, include local ischemia, embolism, cerebral hemorrhage, transient ischemic attack, myocardial ischemia or other arterial thrombosis.
•Any serious medical condition, lab abnormality or psychiatric illness within 6 months prior to enrollment.
•History of malignancies other than curatively treated non-melanoma skin or in situ carcinoma.
•Estimated survival time < 6 months.
•Plan to get major surgery which will lead to massive bleeding during the study.
•Treatment with any other investigational drug within 6 weeks prior to enrollment, or plan to participate in any other investigational drug during the study.
•Any other condition not specifically noted above which, in the judgement of the investigator, would preclude the patient from participating in the study.