NL-OMON50391已完成2 期
A Phase 2, Multicenter, Open-Label, Extension Study to Evaluate the Long-Term Administration of ALN-GO1 in Patients with Primary Hyperoxaluria Type 1. - ALN-GO102
Alnylam Pharmaceuticals, Inc0 个研究点目标入组 2 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 99（—）
入选标准
- •1. Enrollment within 12 months of completion of Study ALN-GO1-001 and in the
- •opinion of the investigator, tolerated the study drug
- •2. If taking vitamin B6 (pyridoxine), willing to remain on a stable regimen for
- •the study duration
- •3. Women of child-bearing potential must have a negative pregnancy test, cannot
- •be breast feeding, and must be willing to use a highly effective method of
- •contraception from 14 days before first dose and throughout study participation
- •until the completion of the follow-up period.
- •4. Willing and able to comply with the study requirements and to provide
- •written informed consent and assent in the case of patients under the age of
- •legal consent, per local and national requirements.
排除标准
- •1. Any uncontrolled or serious disease, or any medical or surgical condition
- •(with the exception of PH1) that may either interfere with participation in the
- •clinical study, and/or put the patient significant risk (according to the
- •Investigator*s judgment) if he/she participates in the clinical study
- •2. An underlying known disease or surgical or medical condition (with the
- •exception of PH1) that in the opinion of the investigator might interfere with
- •the interpretation of the clinical study results
- •3. Requirement for chronic dialysis
- •4. Triplicate 12-lead ECG with clinically significant abnormalities at Baseline
- •visit, at the discretion of the investigator
- •5. Echo assessment of abnormal left ventricular systolic function, defined as
- •left ventricular ejection fraction <55% at Screening
- •6. Abnormal for aspartate aminotransferase (AST)/alanine aminotransferase (ALT)
- •and any other clinical safety laboratory result considered clinically
- •significant and unacceptable by the Investigator at Baseline, at discretion of
- •investigator
- •7. Legal incapacity or limited legal capacity at Screening of patient, parent,
- •or legal guardian
研究者
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