NCT03941236已完成3 期
An Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon for the Treatment of Children With Congenital Hyperinsulinism
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 17
- 主要终点
- Adverse Events
研究概览
简要总结
This is an open-label, multinational, multicenter, long-term safety and efficacy extension trial in patients with Congenital Hyperinsulinism (CHI) who completed either ZP4207-17103 (NCT04172441) or ZP4207-17109 (NCT03777176) (defined as lead-in trials).
The primary objective is to evaluate the long-term safety of dasiglucagon administered as a subcutaneous (SC) infusion in children with CHI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Weeks 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed treatment in either Trial ZP4207-17103 or ZP4207-17109
- •Expected to continue to have a positive benefit-risk assessment for treatment with dasiglucagon (based on considerations of glycemic effect, tolerability, and nature and frequency of adverse events experienced in the lead-in trial)
排除标准
- •The patient developed any conditions prohibited by the lead-in trial, requires medication prohibited by the lead-in trial, or has other new complications that preclude participation in the investigator's opinion.
研究组 & 干预措施
Dasiglucagon open-label
Experimental
Dasiglucagon treatment as an SC infusion in the dose range 10-70 μg/h titrated individually
干预措施: dasiglucagon (Drug)
结局指标
主要结局
Adverse Events
时间窗: Baseline through treatment completion, up to 3 years
Number of adverse events occurring up to Month 1, Month 1 to Month 3 and in each 3-month period for the first year; subsequent years will have longer periods assigned for analysis
次要结局
- Gastric carbohydrate administrations(Baseline through treatment completion, up to 3 years)
- Nightly gastric carbohydrate administrations(Baseline through treatment completion, up to 3 years)
- Extent of hypoglycemia(Baseline through treatment completion, up to 3 years)
- Diazoxide dose(Baseline through treatment completion, up to 3 years)
- Time in hypoglycemia(Baseline through treatment completion, up to 3 years)
- Amount of gastric carbohydrates administered to treat hypoglycemia(Baseline through treatment completion, up to 3 years)
- Nasogastric (NG) tube or gastrostomy removal(Baseline through treatment completion, up to 3 years)
- Pancreatic surgery(Baseline through treatment completion, up to 3 years)
- Hypoglycemia episodes(Baseline through treatment completion, up to 3 years)
- Clinically significant episodes of hypoglycemia(Baseline through treatment completion, up to 3 years)
- Extent of clinically significant hypoglycemia(Baseline through treatment completion, up to 3 years)
- Somatostatin analog dose(Baseline through treatment completion, up to 3 years)
- Prescribed amount of continuous gastric carbohydrate administration(Baseline through treatment completion, up to 3 years)
- Prescribed duration of continuous gastric carbohydrate administration(Baseline through treatment completion, up to 3 years)
- Prescribed duration of nightly continuous gastric carbohydrate administration(Baseline through treatment completion, up to 3 years)
研究者
研究点 (17)
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