NCT00004398已完成1 期
Phase I Study of Heme Arginate With or Without Tin Mesoporphyrin in Patients With Acute Attacks of Porphyria
National Center for Research Resources (NCRR)0 个研究点目标入组 24 人开始时间: 1998年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
OBJECTIVES: I. Evaluate the efficacy of tin mesoporphyrin in patients with acute porphyria attacks who are also treated with a standard course of heme arginate.
II. Evaluate the safety and tolerability of tin mesoporphyrin when administered to these patients.
详细描述
PROTOCOL OUTLINE: This is an randomized, unblinded, multicenter study. Patients are randomized to receive heme arginate alone or both heme arginate and tin mesoporphyrin.
Patients receive a single intravenous dose of tin mesoporphyrin immediately before the first dose of heme arginate. Heme arginate is administered daily for 4 days.
Patients are followed at 3 and 6 days after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Documented acute intermittent porphyria, variegate porphyria, or hereditary coproporphyria
- •No chronic or subacute symptoms (present for longer than 2 weeks)
- •-Prior/Concurrent Therapy--
- •At least 3 weeks since prior treatment with heme arginate or tin mesoporphyrin
- •-Patient Characteristics--
- •Renal: Urinary porphobilinogen at least 40 mg/24 hr
- •Not pregnant
- •Fertile female patients must use effective contraception during and 6 months before study
- •No evidence that symptoms are due to another acute illness
- •No acute hemorrhagic disorder such as: Gastrointestinal bleeding Intracerebral hemorrhage
- •No known sensitivity to heme preparation or tin mesoporphyrin
- •No other medical condition that might increase risk to patient
排除标准
- 未提供
研究者
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