临床试验/NCT01435629

NCT01435629已完成不适用

Open-label, Multicenter, Observational, Non-intervention Study to Retrospectively Evaluate the Efficacy of Norditropin® (Adult Height) in Patients With Achondroplasia/Hypochondroplasia Enrolled in the GH-1941 Study [Follow-up Survey]

Novo Nordisk A/S1 个研究点分布在 1 个国家目标入组 81 人开始时间: 2012年11月22日最近更新: 2017年5月5日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Novo Nordisk A/S
入组人数: 81
试验地点: 1
主要终点: To collect change data of adult height (cm) of patients treated with Norditropin® and evaluate the long-term efficacy

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 study is conducted in Japan. The aim of the study is to evaluate the efficacy of somatropin (Norditropin®) on adult height (cm) in patients with achondroplasia / hypochondroplasia enrolled in the GH-1941 study (NCT01516229).

研究设计

研究类型: Observational
观察模型: Other
时间视角: Retrospective

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Patients who were enrolled in the GH-1941 study (1997 to 2006) and expected to theoretically reach the adult height within the study period

排除标准

未提供

研究组 & 干预措施

Norditropin®

干预措施: somatropin (Drug)

结局指标

主要结局

To collect change data of adult height (cm) of patients treated with Norditropin® and evaluate the long-term efficacy

时间窗: At year 1, 2, 3, 4, and 5 after the patient has reached adult height or is 18 of age

次要结局

To monitor the patients to see if they undergo lower limb lengthening(At year 1, 2, 3, 4, and 5 after the patient has reached adult height or is 18 of age)

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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