NCT04056481Approved For Marketing不适用
Expanded Access Protocol of Givosiran for Patients With Acute Hepatic Porphyria (AHP)
Alnylam Pharmaceuticals0 个研究点开始时间: 2019年8月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Approved For Marketing
- 发起方
研究概览
简要总结
The purpose of this study is to provide expanded access of givosiran to patients with Acute Hepatic Porphyria (AHP).
详细描述
Choosing to participate in an expanded access program is an important personal decision. Talk with your doctor and family members or friends about deciding to join a research study. To learn more about this study, please have your doctor contact the study research staff using the Contacts provided. For general information, see the link provided in More Information.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Acute Hepatic Porphyria (Acute Intermittent Porphyria, Hereditary Coproporhyria, Variegate Porphyria, ALA dehydratase deficient porphyria)
- •Have adequate venous access for program sample collections as judged by the Investigator for study sample collections
排除标准
- •Previously or currently participating in a givosiran clinical trial
- •Has any of the following laboratory parameter assessments at Screening:
- •Alanine aminotransferase (ALT) >2×ULN
- •Total bilirubin >1.5×ULN. Patients with elevated total bilirubin that is secondary to documented Gilbert's syndrome are eligible if the total bilirubin is <2×ULN
- •Estimated Glomerular Filtration Rate (eGFR) <15 mL/min/1.73 m2
- •On an active liver transplantation waiting list
研究者
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