A Pilot Study to Establish Incidence and Characteristics of Patients at Risk for Symptomatic Hyperammonemia Secondary to Recombinant Erwinia Asparaginase
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence of patients who develop hyperammonemia
研究概览
简要总结
This study evaluates the incidence of symptomatic hyperammonemia (high ammonia levels) in patients being treated with recombinant Erwinia asparaginase.
详细描述
PRIMARY OBJECTIVE:
I. To determine incidence of patients who develop hyperammonemia secondary to recombinant Erwinia asparaginase.
II. To characterize patients at risk for hyperammonemia secondary to recombinant Erwinia asparaginase.
OUTLINE: This is an observational study.
Patients undergo blood sample collection, complete surveys, and have their medical records reviewed on study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Followed by pediatric hematology/oncology
- •Receiving recombinant Erwinia asparaginase for treatment of malignancy
排除标准
- •Patients < 1 year of age
- •Patients who have previously received recombinant Erwinia asparaginase within the past two weeks
研究组 & 干预措施
Observational
Patients undergo blood sample collection, complete surveys, and have their medical records reviewed on study.
干预措施: Non-Interventional Study (Other)
结局指标
主要结局
Incidence of patients who develop hyperammonemia
时间窗: Up to 12 months
Assessed by measuring ammonia levels via blood test. Baseline ammonia level will be determined around the time of consent. During the first two recombinant Erwinia asparaginase (Rylaze®) courses, there will be two blood draws per week. Each course of recombinant Erwinia asparaginase (Rylaze®) lasts for two weeks, so there will be four blood draws per course.
次要结局
未报告次要终点