NCT00675103已完成3 期
Multicenter, Open-Label, 24 Week Regimen of 8 mg Pegloticase i.v. in Symptomatic Gout Subjects Who Participated in Previous Studies of Pegloticase i.v.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- Adverse Event Profile
研究概览
简要总结
The purpose of the study is to evaluate the safety and clinical effect of re-exposure to a 24 week course of treatment of pegloticase i.v. in subjects whose last exposure to pegloticase i.v. was at least one year before study entry.
This study is limited to four study centers in the US.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Previous treatment in studies of pegloticase i.v.
- •Last exposure to pegloticase i.v. greater than one year prior to study entry
- •Symptomatic gout
- •Documented hyperuricemic (SUA ≥ 7 mg/dL)
排除标准
- •Prior exposure to Elitek® (rasburicase)
- •Unstable angina
- •Uncontrolled arrhythmia or hypertension
- •Non-compensated congestive heart failure
- •End stage renal disease requiring dialysis
- •Concomitant use of SUA lowering agents and use of other investigational drugs
研究组 & 干预措施
pegloticase
Experimental
干预措施: pegloticase 8 mg i.v. (Drug)
结局指标
主要结局
Adverse Event Profile
时间窗: 6 months
Number of participants reporting events
次要结局
- Mean Plasma Uric Acid(Baseline, Week 3 and Week 7)
研究者
研究点 (4)
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