NCT01573754已完成2 期
A Prospective Comparison of Low Dose Hydroxychloroquine and Phlebotomy in the Treatment of Porphyria Cutanea Tarda. IRB 02-435
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Remission
研究概览
简要总结
Porphyria cutanea tarda (PCT) is an iron-related disorder that responds to treatment by phlebotomy or low-dose hydroxychloroquine, but comparative data on these treatments are limited. The hypothesis is that hydroxychloroquine is noninferior to phlebotomy in terms of time to remission. Patients with well documented PCT are assigned to treatment by randomization if specific criteria are met. All patients are followed until remission - defined as achieving a normal plasma porphyrin concentration.
详细描述
Study Design: Pragmatic Interventional study
Primary Study Objective: To determine and compare time to remission with treatment with low-dose hydroxychloroquine or repeated phlebotomy in participants with PCT.
Secondary Study Objective(s):
- To assess the effects of susceptibility factors on responses to treatment of PCT by these methods.
- To determine and compare rates of recurrence of PCT after treatment with low-dose hydroxychloroquine or phlebotomy.
Study Population and Main Eligibility/ Exclusion Criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented porphyria cutanea tarda (PCT)
- •Willing to give informed consent
- •Age 18 or greater
排除标准
- •Blistering skin lesions due to another condition
研究组 & 干预措施
Hydroxychloroquine
Experimental
Low-dose hydroxychloroquine 100 mg by mouth twice weekly
干预措施: Hydroxychloroquine (Drug)
Phlebotomy
Active Comparator
Phlebotomy 450 mL biweekly
干预措施: Phlebotomy (Procedure)
结局指标
主要结局
Remission
时间窗: To end of study, an average of 3 years
Time to a decrease in plasma porphyrin concentration to less than 0.9 mcg/dL
次要结局
- Number of Days With Normal Urinary Porphyrin Levels(To end of study, an average of 3 years)
- 75% Reduction in Plasma Porphyrin Level(To end of study, an average of 3 years)
- 50% Reduction in Plasma Porphyrin Level(To end of study, an average of 3 years)
研究者
研究点 (1)
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