2024-519009-36-01招募中2 期
Use of pegfilgrastim in severe chronic neutropenia
IRCCS Istituto Giannina Gaslini1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年1月31日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Median of absolute neutrophil count (from second to six months-period of study)
研究概览
简要总结
Evaluation of the pegG-CSF efficacy in maintaining absolute neutrophil values above 1000/mmc in patients affected with severe chronic neutropenia (SCN) already being treated with G-CSF (once daily) and anti-infective therapy.
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Patients, none age limits, affected with either congenital or acquired chronic neutropenia defined as absolute neutrophil count < 500/mmc (based on three consecutive tests at least one week apart within a minimum three-months period) already being treated with G-CSF (daily).
排除标准
- •Subjects affected with autoimmune neutropenias or idiopathic neutropenia that are not being treated/occasionally treated with growth factor
- •Subjects affected with iatrogenic neutropenia anticancer drug-induced
- •Subject affected with neutropenia induced by myelodysplastic syndrome and or leukemia with/without clonal cytogenetic abnormalities
- •Subject affected with acquired or congenital neutropenia diagnosis
- •Subjects affected with hepatic or renal impairment
- •Subjects affected with homozygous sickle cell disease or subjects affected with double heterozygosity inheritance of HbS and β-thalassemia
- •Pregnancy and nursing woman
结局指标
主要结局
Median of absolute neutrophil count (from second to six months-period of study)
Median of absolute neutrophil count (from second to six months-period of study)
次要结局
- Number, type and duration of the infections (from second to six months-period of study)
- Number of antibiotic courses (from second to six months-period of study)
- Numbero of hospitalizations (from second to six months-period of study)
研究者
Francesca Fioredda
Scientific
IRCCS Istituto Giannina Gaslini
研究点 (1)
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