This is a non-interventional registry of children treated with Norditropin® for short stature due to Noonan Syndrome (NS). This study aims to provide data on long-term growth evolution and safety of Norditropin® as well as Health Related Quality of Life (HRQoL) data. This registry will include the entirety of children treated with Norditropin® for short stature due to NS over the inclusion period. The decision to initiate treatment with commercially available Norditropin® is made by the patient/parents/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.

开始日期2022-03-16

申办/合作机构

Novo Nordisk A/S

CTRI/2020/03/024055 / Completed临床1期

A Randomised, Open-labelled, Active-controlled, Single and Multiple Dose, Dose Escalating, Sequential Dose Group, Parallel Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Once weekly long-acting Recombinant Growth Hormone (ALT-P1) Compared to Once daily growth hormone (NorditropinÃ?Â®) in Healthy Subjects.

开始日期2021-01-04

申办/合作机构

Alteogen, Inc.

NCT04042428 / Completed临床1期IIT

Generation of Biological Samples Positive to Somatropin for Anti-doping Control

Background:
Somatropin, also known as recombinant growth hormone (rhGH), is one of the World Anti-Doping Agency (WADA) prohibited substances. Its consumption in athletes has been banned since 1990, as it is known to improve physical performance.
Hypothesis:
The subcutaneous administration of recombinant somatropin (rhGH) in healthy subjects allows obtaining positive doping samples.
The concentrations of hGH variants (isoforms) and biomarkers can be measured in serum.
Objectives:
Primary objective: To generate enough serum samples positive to recombinant somatropin in order to be analyzed as control samples by anti-doping laboratories.
Secondary objective: To determine the analytical parameters necessary to detect the administration of recombinant somatropin in healthy volunteers by direct and/or indirect methods.
Methods:
Phase I, open, randomized clinical trial, with a treatment condition (recombinant somatropin or rhGH) administered subcutaneously to 4 subjects (2:1 ratio). Control samples of the study correspond to basal samples of 2 subjects who do not receive any treatment.

开始日期2019-10-25

申办/合作机构

Consorci Mar Parc de Salut de Barcelona

100 项与重组人生长激素(Novo Nordisk A/S) 相关的临床结果

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100 项与重组人生长激素(Novo Nordisk A/S) 相关的转化医学

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100 项与重组人生长激素(Novo Nordisk A/S) 相关的专利（医药）

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132

项与重组人生长激素(Novo Nordisk A/S) 相关的文献（医药）

2024-02-01·Current medical research and opinion

Health-related quality of life in pre-pubertal children with pediatric growth hormone deficiency: 12-month results from a phase 3 clinical trial of once-weekly somatrogon versus once-daily somatropin

Article

作者: Valluri, Srinivas Rao ; Quitmann, Julia ; Loftus, Jane

OBJECTIVE:

Treatment of pediatric growth hormone deficiency (pGHD) with daily injection of recombinant human growth hormone (somatropin) aims to increase height velocity and improve health-related quality of life (HRQoL). The Quality of Life in Short Stature Youth (QoLISSY) questionnaire was administered in a phase 3 clinical trial that evaluated efficacy and safety of once-weekly somatrogon versus once-daily somatropin in children with pGHD (ClinicalTrials.gov no NCT02968004).

METHODS:

Treatment-naïve prepubertal children with pGHD received once-weekly somatrogon or once-daily somatropin for 12 months. The QoLISSY core module (physical/social/emotional subscales) was administered at baseline and 12 months after treatment initiation. QoLISSY-Parent was completed by parents/caregivers of children <7 years old and some parents/caregivers of children ≥7 years old; children ≥7 years old self-completed QoLISSY-Child.

RESULTS:

Baseline characteristics were similar between treatment groups (N = 117). Among children <7 years old, QoLISSY-Parent total and subscale scores showed similarly improved HRQoL at 12 months relative to baseline in both treatment groups. Self-reported QoLISSY-Child total and subscale scores in children ≥7 years old indicated HRQoL improvements at 12 months that were numerically better with somatrogon than somatropin (similar results with QoLISSY-Parent in this age group). At both time points, children reported better HRQoL than perceived by their parents/caregivers.

CONCLUSION:

Treatment for 12 months with once-weekly somatrogon or once-daily somatropin resulted in comparable improvements in HRQoL among children with pGHD. Lower HRQoL perceived by parents/caregivers possibly reflect children's tendency to emphasize adaptation. These results suggest that evaluation of HRQoL could help support treatment decisions in children with pGHD treated with growth hormone.

2023-09-18·The Journal of clinical endocrinology and metabolism

Early GH Treatment Is Effective and Well Tolerated in Children With Turner Syndrome: NordiNet® IOS and Answer Program

Article

作者: Verlinde, Franciska ; Blair, Joanne C ; Polak, Michel ; Miller, Bradley S ; Sävendahl, Lars ; Pietropoli, Alberto ; Rohrer, Tilman R ; Backeljauw, Philippe ; Kelepouris, Nicky ; Ferran, Jean-Marc

Abstract:

Context:

Despite having normal growth hormone (GH) secretion, individuals with Turner syndrome (TS) have short stature. Treatment with recombinant human GH is recommended for TS girls with short stature.

Objective:

This work aimed to evaluate the effectiveness and safety of Norditropin (somatropin, Novo Nordisk) with up to 10 years of follow-up in children with TS.

Methods:

Secondary analysis was conducted of Norditropin data from 2 non-interventional studies: NordiNet® IOS (NCT00960128) and the ANSWER program (NCT01009905).

Results:

A total of 2377 girls with TS were included in the safety analysis set (SAS), with 1513 in the treatment-naive effectiveness analysis set (EAS). At the start of treatment, 1273 (84%) participants were prepubertal (EAS); mean (SD) age was 8.8 (3.9) years. Mean (SD) dose received at the start of GH treatment was 0.045 (0.011) mg/kg/day (EAS). Mean (SD) baseline insulin-like growth factor-1 (IGF-I) SD score (SDS) was −0.86 (1.52), and mean (SD) duration of GH treatment (SAS) was 3.8 (2.8) years.Height SDS (HSDS) increased throughout follow-up, with near-adult HSDS reached by 264 (17%) participants (mean [SD] −1.99 [0.94]; change from baseline +0.90 [0.85]). During the study, 695 (46%) participants (EAS) entered puberty at a mean (SD) age of 12.7 (1.9) years (whether puberty was spontaneous or induced was unknown). Within the SAS, mean IGF-I SDS (SD) at year 10 was 0.91 (1.69); change from baseline +1.48 (1.70). Serious adverse reactions were reported in 10 participants (epiphysiolysis [n = 3]).

Conclusion:

GH-treated participants with TS responded well, without new safety concerns. Our real-world data are in agreement with previous studies.

2023-05-05·Journal of the Endocrine Society

Long-term Effectiveness and Safety of GH Replacement Therapy in Adults ≥60 Years: Data From NordiNet® IOS and ANSWER

Article

作者: Olsen, Anne Helene ; Weber, Matthias M ; Nedjatian, Navid ; Gordon, Murray B ; Höybye, Charlotte ; Kelepouris, Nicky ; Biller, Beverly M K ; Ferran, Jean-Marc

Abstract:

Context:

Effectiveness and safety data on GH replacement therapy (GHRT) in older adults with adult GH deficiency (AGHD) are limited.

Objective:

To compare GHRT safety and clinical outcomes in older (≥60 years and, for some outcomes, ≥75 years) and middle-aged (35–<60 years) patients with AGHD.

Design/setting:

Ten-year follow-up, real-world data from 2 large noninterventional studies—NordiNet® International Outcome Study (IOS) and the American Norditropin® Studies: Web-Enabled Research (ANSWER) Program—were analyzed.

Patients:

GH-naïve and non-naïve patients with AGHD.

Intervention:

Norditropin® (somatropin).

Main outcome measures:

Outcomes included GH exposure, IGF-I standard deviation scores (SDS), body mass index (BMI), glycated hemoglobin (HbA1c), serious and nonserious adverse reactions (SARs and NSARs, respectively), and serious adverse events (SAEs). Adverse reactions were events with possible/probable causal relationship to GHRT.

Results:

The effectiveness analysis set comprised 545 middle-aged and 214 older patients (19 aged ≥75 years) from NordiNet® IOS. The full analysis set comprised 1696 middle-aged and 652 older patients (59 aged ≥75 years) from both studies. Mean GH doses were higher in middle-aged vs older patients. For both age groups and sexes, mean IGF-I SDS increased following GHRT, while BMI and HbA1c changes were similar and small.Incidence rate ratios (IRRs) did not differ statistically between older and middle-aged patients for NSARs [IRR (mean, 95% confidence interval) 1.05 (.60; 1.83)] or SARs [.40 (.12; 1.32)]. SAEs were more frequent in older than middle-aged patients [IRR 1.84 (1.29; 2.62)].

Conclusion:

Clinical outcomes of GHRT in AGHD were similar in middle-aged and older patients, with no significantly increased risk of GHRT-related adverse reactions in older patients.

项与重组人生长激素(Novo Nordisk A/S) 相关的新闻（医药）

2024-12-09

·Insight数据库

每周给药一次！「伊坦长效生长激素」报上市

12 月 9 日，天境生物与济川药业联合宣布伊坦长效生长激素上市申请已获 NMPA 受理，有望为中国生长激素缺乏症患儿提供安全、有效且每周一次给药的便利治疗选择。截图来源：企业官微 2021 年 11 月，天境生物与济川药业就伊坦长效生长激素达成战略合作，加速其在中国大陆的产品开发、生产及商业化进程。天境生物将作为上市许可持有人（MAH）负责向国家药品监督管理局递交伊坦长效生长激素的上市许可注册申请，并向济川药业供药。济川药业将就伊坦长效生长激素合作拓展其他新适应症，并在该产品获批后负责在中国市场进行商业化推广，天境生物将从临床、生产及学术等多方面提供支持。伊坦长效生长激素是国内申报阶段和已上市产品中首款且唯一一款融合蛋白长效重组人生长激素，旨在为生长激素缺乏症患者提供更安全、便捷、有效的创新疗法。该产品采用创新的 hyFc®融合蛋白技术，通过将人生长激素与特殊设计的人免疫球蛋白相结合，显著提升了药物的稳定性和半衰期，实现了每周一次给药的突破性治疗方案。此前伊坦长效生长激素完成了一项 III 期、随机、开放标签、阳性药物平行对照研究 (CTR20202305)，旨在评估该药对生长激素缺乏症儿童患者的疗效和安全性。研究结果显示伊坦长效生长激素展现出卓越的疗效和安全性: 伊坦长效生长激素治疗 52 周后达到主要研究终点，验证了与阳性对照药物 (每日给药生长激素制剂诺泽®) 比较的非劣效性; 伊坦长效生长激素为每周一次给药，患儿年化生长速率 (AHV) 为 10.76 厘米/年 vs 对照药物为每日一次给药，AHV 为 10.28 厘米/年，组间差异 0.47(95% 置信区间-0.06,1.00,p<0.0001); 安全性结果显示，伊坦长效生长激素耐受性良好，未发生因治疗相关的不良事件停药，安全性特征与对照药物相当。截图来源：Insight 数据库封面来源：站酷海洛题图免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：ccai PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn 多样化功能、可溯源数据…… Insight 数据库网页版等你体验点击阅读原文，立刻解锁！

临床3期临床结果突破性疗法

2024-12-09

·药研网

天境生物/济川药业：长效生长激素申报上市

12月9日，天境生物官方宣布，伊坦生长激素（eftansomatropin alfa，TJ101）治疗儿童生长激素缺乏症(PGHD)的生物制品上市申请(BLA)已获得中国国家药品监督管理局(NMPA)受理。据其新闻稿，作为国内申报阶段和已上市产品中首款且唯一一款融合蛋白长效生长激素，该创新疗法有望为儿童生长激素缺乏症患者带来安全、有效且更具便利性的治疗方案在2023年半年报中，天境生物曾提到伊坦生长激素对比Norditropin（诺泽）治疗儿童生长激素缺乏症的III期研究达到非劣效性主要终点。伊坦生长激素是Genexine开发的一款长效生长激素，通过刺激肝脏中胰岛素样生长因子1（IGF-1）的产生，对各种细胞和组织发挥生长刺激作用。 2021年11月10日，天境生物与济川药业举行战略合作签约仪式，就前者的伊坦生长激素（eftansomatropin alfa，TJ101）达成产品开发、生产及商业化战略合作。据悉，此项合作总金额高达20.16亿人民币，交易金额创下了近年中国生物医药市场及全球儿科医药领域同类新高。此次完成的III期研究（代号：CTJ101PGHD301）是一项开放标签、阳性药物对照的临床试验，共纳入336例3-10岁儿童生长激素缺乏症患者，旨在对比伊坦生长激素（1.2mg/kg，每周1次）和诺泽（0.034mg/kg，每天1次）的有效性和安全性。研究的主要终点为第52周受试者的年化身高生长速率（AHV）。结果显示，伊坦生长激素组患者的AHV为10.76厘米/年，Norditropin组患者的AHV为10.28厘米/年，达到非劣效性要求（P<0.0001)。安全性方面，伊坦生长激素耐受性良好，未见报告治疗相关不良事件导致的停药事件。目前，国内已有多款生长激素获批上市，包括尤得盼（LG Chem）、安苏萌（安科生物）、诺泽（诺和诺德）和金赛增（金赛药业）等。金赛增是一种聚乙二醇重组人生长激素，注射频率为每周1次。 End 声明：本公众号所有发文章(包括原创及转载文章)系出于传递更多信息之目的，且注明来源和作者。本公众号欢迎分享朋友圈或大群，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载/商务/投稿 | 联系微信15618157102（sum_Gmi）商务合作稿件征集点击了解详情往期回顾 1 10月 | 20家生物医药裁员汇总 2 国产首款四价HPV疫苗拟纳入优先审评 3 3. 7亿美元!今年规模最大的生物医药融资诞生

临床3期优先审批疫苗临床结果上市批准

2024-12-07

·医药魔方Info

一年长高10.76厘米！天境生物长效生长激素申报上市

12月7日，CDE网站显示，天境生物的伊坦生长激素（eftansomatropin alfa，TJ101）申报上市。在2023年半年报中，天境生物曾提到伊坦生长激素对比Norditropin（诺泽）治疗儿童生长激素缺乏症的III期研究达到非劣效性主要终点。伊坦生长激素是Genexine开发的一款长效生长激素，通过刺激肝脏中胰岛素样生长因子1（IGF-1）的产生，对各种细胞和组织发挥生长刺激作用。2015年10月，天士力子公司Tasgen（后来被天境生物收购）与Genexine达成协议，获得伊坦生长激素的中国权益。2021年11月，天境生物将该产品的商业化权益授权给济川药业。来源：天境生物官网此次完成的III期研究（代号：CTJ101PGHD301）是一项开放标签、阳性药物对照的临床试验，共纳入336例3-10岁儿童生长激素缺乏症患者，旨在对比伊坦生长激素（1.2mg/kg，每周1次）和诺泽（0.034mg/kg，每天1次）的有效性和安全性。研究的主要终点为第52周受试者的年化身高生长速率（AHV）。结果显示，伊坦生长激素组患者的AHV为10.76厘米/年，Norditropin组患者的AHV为10.28厘米/年，达到非劣效性要求（P<0.0001)。安全性方面，伊坦生长激素耐受性良好，未见报告治疗相关不良事件导致的停药事件。目前，国内已有多款生长激素获批上市，包括尤得盼（LG Chem）、安苏萌（安科生物）、诺泽（诺和诺德）和金赛增（金赛药业）等。金赛增是一种聚乙二醇重组人生长激素，注射频率为每周1次。 Copyright © 2024 PHARMCUBE. All Rights Reserved. 欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。精彩预告线上直播 ↑点击扫码，直达直播间↑

临床3期并购上市批准引进/卖出

100 项与重组人生长激素(Novo Nordisk A/S) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	重组人生长激素(Novo Nordisk A/S)	H01AC01	DB00052

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
生长障碍	中国	Novo Nordisk A/S	1999-06-22
生长激素缺乏症	中国	Novo Nordisk A/S	1999-06-22
侏儒症	日本	Novo Nordisk Pharma Ltd.	1991-01-18
垂体性侏儒症	日本	Novo Nordisk Pharma Ltd.	1988-11-30

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
胎儿生长受限	临床3期	日本	Novo Nordisk A/S	2004-08-18
小于胎龄儿	临床3期	日本	Novo Nordisk A/S	2004-08-18

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ESPE2015	N/A	特纳综合症	-	Recombinant GH	醖顧願構製築顧繭鏇鑰(繭鑰獵憲衊鬱衊網齋醖) = she started treatment with acetazolamide with good effect 蓋選淵餘醖構觸範鹽憲 (鹽憲積艱顧夢積簾鑰醖 ) 更多	-	2015-10-01
Pubmed \| Patient Prefer Adherence	临床4期	-	103	Norditropin NordiFlex	醖鑰鑰繭鹹膚繭鑰艱獵(顧顧衊顧製顧獵壓壓製) = 壓願獵醖獵衊簾遞鏇衊鑰廠網選憲網觸齋觸鏇 (窪襯顧壓鹽淵選壓顧窪 ) 更多	-	2013-05-01