临床试验/NCT01973244

NCT01973244已完成1 期

A Randomised, Open-labelled, Active-controlled, Multinational, Dose-escalation Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (NNC0195-0092, Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 32 人开始时间: 2013年12月16日最近更新: 2020年12月24日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 32
试验地点: 1
主要终点: Incidence of adverse events (AEs)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This trial is conducted in Europe and Asia. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of a single dose of long-acting growth hormone (NNC0195-0092, somapacitan) compared to daily dosing of Norditropin® SimpleXx® (somatropin) in children with growth hormone deficiency.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 6 Years 至 13 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•Confirmed diagnosis of GHD (growth hormone deficiency) as defined by two different GH (growth hormone) stimulation tests, peak GH level below or equal to 7.0 ng/ml. For children with three or more pituitary hormone deficiencies only one GH stimulation test will be needed. If in accordance with country specific practice, growth hormone deficiency can be defined by only one GH stimulation test, peak GH level below or equal to 7.0 ng/ml.
•Pre-pubertal children at screening. Boys: Tanner stage 1 and age above or equal to 6 years and below 13 years. Girls: Tanner stage 1 and age above or equal to 6 years and below 12 years
•Body weight above or equal to 16.0 kg and below or equal to 50.0 kg
•Stable GH replacement treatment for at least 3 months

排除标准

•History or presence of malignancy
•Overt diabetes mellitus (fasting blood glucose above or equal to 7.0 mmol/l)

研究组 & 干预措施

NNC0195-0092 (somapacitan)

Experimental

干预措施: somapacitan (Drug)

Norditropin®

Active Comparator

干预措施: somatropin (Drug)

结局指标

主要结局

Incidence of adverse events (AEs)

时间窗: From first administration of trial product and up until day 35 (final visit)

次要结局

The area under the insulin-like growth factor I (IGF-I) concentration-time curve(From 0 to 168 hours after dosing)

研究者

发起方

Novo Nordisk A/S

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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