NL-OMON44062已完成不适用
A Phase 1 Study of DCR-PH1 in Patients with Primary Hyperoxaluria Type 1 (PH1) - DICERNA: DCR-PH1-101
Dicerna Pharmaceuticals, lnc0 个研究点目标入组 7 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Diagnosis of PH1, confirmed by genotyping for homozygosity or compound heterozygosity in
- •the AGXT gene (historically available genotype information is acceptable for study eligibility).
- •- 24-hour urine oxalate excretion * 0.7 mmol per 1.73 m2 body surface area (BSA).
- •- Estimated glomerular filtration rate * 40 mL/min normalized to 1.73 m2 BSA calculated using
- •the Modification of Diet in Renal Disease (MDRD) formula in adults (age * 18 years).
排除标准
- •- Prior renal and/or hepatic transplantation.
- •- History of clinical signs and symptoms of systemic oxalosis other than nephrolithiasis or
- •nephrocalcinosis.
- •- Participation in any clinical study involving administration of any investigational drug within
- •the 30 days before enrollment
研究者
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