临床试验/NCT00936403

NCT00936403已完成2 期

A Randomised, Open-labelled, Single Dose, Dose-escalation Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Pegylated Long-acting Human Growth Hormone (NNC126-0083) Compared to Norditropin NordiFlex® in Growth Hormone Deficient Children

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 31 人开始时间: 2009年8月最近更新: 2017年2月8日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 31
试验地点: 1
主要终点: Frequency 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. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics (the determination of the concentration of the administered medication in blood over time) and pharmacodynamics (the determination of the effect over time and the duration of action) of a long-acting growth hormone (NNC126-0083) in growth hormone deficient children.

研究设计

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

入排标准

年龄范围: 6 Years 至 12 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•Confirmed diagnosis of growth hormone insufficiency as defined by two different GH provocation tests, defined as a peak of GH level less than 7ng/ml
•Pre-pubertal children
•Growth hormone replacement treatment for at least three months

排除标准

•Evidence of tumour growth or malignant disease
•Growth hormone deficient children with overt diabetes mellitus (fasting blood glucose more than 126mg/dl)

研究组 & 干预措施

NNC126-0083

Experimental

干预措施: NNC126-0083 (Drug)

Norditropin NordiFlex®

Active Comparator

干预措施: somatropin (Drug)

结局指标

主要结局

Frequency of Adverse events (AEs)

时间窗: 0-10 days after dosing

次要结局

AUC (0-168h), the area under the plasma NNC126-0083 profile in the interval 0-168 hours after trial product administration(Measured 10 days after dosing)
IGF-I AUC (0-168h) the area under IGF-I profile in the interval 0-168 hours after trial product administration(Measured 10 days 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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