NL-OMON53697招募中3 期
An open-label, single arm, multicenter extension study to evaluate long-term safety and tolerability of inclisiran in participants with heterozygous or homozygous familial hypercholesterolemia who have completed the adolescent ORION-16 or ORION-13 studies (VICTORION-PEDS-OLE) - CKJX839C12001B, VICTORION-PEDS-OLE
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- ovartis
- 入组人数
- 23
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
- 12 至 64（—）
入选标准
- •Male and female participants with a diagnosis of HeFH or HoFH who completed
- •ORION-16 or ORION-13 studies, meaning the participant received the last dose of
- •drug and completed the final study visit as per applicable protocol
- •Per investigator`s clinical judgment, participant derived benefit from
- •treatment with
- •inclisiran in the ORION-16 or ORION-13 studies
- •Continuing current lipid-lowering therapies (such as e.g. statin and/or
- •ezetimibe) from the
- •feeder study with no planned medication or dose change
排除标准
- •Participants who in the feeder inclisiran ORION-16 and ORION-13 studies
- •either screen
- •failed or permanently discontinued from the treatment/study for any reason or
- •had serious
- •safety or tolerability issues related to inclisiran treatment
- •Any uncontrolled or serious disease, or any medical, physical, or surgical
- •condition, that
- •may either interfere with participation in the clinical study or interpretation
- •of clinical
- •study results, and/or put the participant at significant risk
- •Active liver disease defined as any known current infectious, neoplastic, or
- •pathology of the liver
研究者
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