NCT00080210已完成2 期
A Phase II Study of Multiple Doses of Intravenous Puricase in Subjects With Hyperuricemia and Refractory Gout
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 18
研究概览
简要总结
This is a randomized, open-label, multicenter, parallel-groups study of multiple intravenous doses of Puricase, administered intravenously, in 40 patients with symptomatic gout. Subjects must wash out of any uric acid-lowering agents for one week before being dosed, and must refrain from using such agents throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects to be included in the study are:
- •Outpatients of either gender, age 18 or older
- •Diagnosed with symptomatic gout refractory to conventional therapy or unable to tolerate conventional therapy (for example: having one or more tophi and/or having experienced a gout flare within the previous 6 months and/or having chronic, gouty arthritis)
- •Hyperuricemic: screening serum uric acid must be >=8 mg/dL.
- •The patient must be willing and able to give informed consent and adhere to visit/protocol schedules (Consent must be given before any study procedures are performed)
- •Women of childbearing potential must have a negative serum pregnancy test and must use an approved birth control method during their participation in the protocol. Such methods include oral, injectable, or implantable contraceptives; IUDs and barrier contraceptives in combination with spermicide
排除标准
- •Subjects to be excluded are those for whom any of the following apply:
- •Unstable coronary artery disease or uncontrolled hypertension
- •History of end stage renal disease requiring dialysis
- •History of liver disease, as defined by baseline serum transaminase elevation >3X the upper limit of normal in the absence of any other known cause
- •Organ transplant recipient requiring immunosuppressive therapy
- •Concurrent use of prednisone at a dose >10 mg qd (or equivalent) at or within one week before dosing
- •Concurrent use of uric acid-lowering agents
- •Prior treatment with Puricase® or other recombinant uricase
- •An acute gout flare within one week prior to first treatment with Puricase® (exclusive of chronic synovitis/arthritis) requiring use of medication which violates the protocol
- •glucose-6-phosphate dehydrogenase deficiency
- •A history of anaphylactic reaction to a recombinant protein or porcine derivatives
- •Lactation
- •Has taken an investigational drug within 4 weeks prior to study drug administration or plans to take an investigational agent during the study
- •Known allergy to urate oxidase or PEGylated products
- •Has any other medical or psychological condition which, in the opinion of the investigator, might create undue risk to the patient or interfere with the patient's ability to comply with the protocol requirements
研究者
研究点 (18)
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