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更新于：2025-01-23
Somatropin (Merck Serono SA)
生长激素(Merck Serono SA)
更新于：2025-01-23
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (1976-07-30) |
最高研发阶段(中国)批准上市 |
特殊审评加速批准 (美国)、孤儿药 (美国) |
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结构/序列
Sequence Code 26401985
当前序列信息引自: *****
关联
22
项与 生长激素(Merck Serono SA) 相关的临床试验NCT03091374
A Proof-of-concept Study to Assess the Effect of Recombinant Human Growth Hormone on the Size of the Replication-competent Viral Reservoir in HIV-infected Individuals on Suppressive Antiretroviral Therapy
NCT01746862
A Randomized, Open-label, Two-arm Parallel Group, No Treatment Group-controlled, Multicenter Phase III Study to Evaluate the Safety and Efficacy of Saizen® 0.067 mg/kg/Day Subcutaneous Injection in Children With Idiopathic Short Stature
NCT01616225
Adjuvant Growth Hormone in Infertile Women With Prior Poor IVF Response: a Randomized, Controlled, Open-label Study
100 项与 生长激素(Merck Serono SA) 相关的临床结果
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100 项与 生长激素(Merck Serono SA) 相关的转化医学
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100 项与 生长激素(Merck Serono SA) 相关的专利（医药）
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45
项与 生长激素(Merck Serono SA) 相关的文献（医药）2025-01-01HUMAN REPRODUCTION
Empirical use of growth hormone in IVF is useless: the largest randomized controlled trial
Article
作者: Tadevosyan, Artak ; Mourad, Ali ; Phillips, Simon ; Jamal, Wael ; Hemmings, Robert ; Kadoch, Isaac-Jacques
Abstract:
STUDY QUESTION:
Does adjuvant growth hormone (GH) therapy in GnRH antagonist cycles improve reproductive outcomes in the general IVF population?
SUMMARY ANSWER:
Empiric adjuvant GH therapy in GnRH antagonist cycles does not improve IVF stimulation results or reproductive outcomes, including implantation, miscarriage, and clinical pregnancy rates.
WHAT IS KNOWN ALREADY:
Previous evidence regarding the benefits of GH therapy in IVF cycles has been inconclusive due to the lack of well-designed, large-scale randomized controlled trials (RCTs) in the general IVF population.
STUDY DESIGN, SIZE, DURATION:
This is a phase III open-label RCT involving 288 patients undergoing antagonist IVF cycles at the Ovo clinic in Montreal, Canada, between June 2014 and January 2020. Patients were randomly assigned at a 1:1 ratio to either the GH or control group. The intervention group received daily 2.5 mg subcutaneous injections of GH from Day 1 of ovarian stimulation until the day of oocyte retrieval, while the control group received standard ovarian stimulation without any adjuvant therapy.
PARTICIPANTS/MATERIALS, SETTING, METHODS:
Patients were expected normal responders. All embryo transfers, both fresh and frozen, resulting from the studied IVF cycle were included in an intention-to-treat and per-protocol analyses. The primary outcome was the clinical pregnancy rate, while secondary outcomes included the number of retrieved oocytes, good-quality embryos, maturation, fertilization, implantation, and miscarriage rates.
MAIN RESULTS AND THE ROLE OF CHANCE:
A total of 288 patients were recruited and randomly assigned at a 1:1 ratio to either the GH or the control group. After excluding cycle cancellations and patients who did not undergo transfer, 105 patients remained in each group. The overall mean age was 38.0 years, the mean BMI was 25.11 kg/m2 and the mean anti-Müllerian hormone was 2.51 ng/ml. The cycle characteristics were similar between both groups. No differences were observed regarding the total dose of gonadotropins (4600 versus 4660 IU for the GH and control groups, respectively, P = 0.752), days of stimulation (11.4 versus 11.7 days, P = 0.118), and endometrial thickness (10.63 versus 10.94 mm, P = 0.372). Both the intention to treat (ITT) and per protocol analyses yielded similar results for stimulation outcomes. In the ITT analysis, no differences were found in the number of follicles ≥15 mm (7.8 versus 7.1, P = 0.212), retrieved oocytes (11.7 versus 11.2, P = 0.613), mature oocytes (8.5 versus 8.6, P = 0.851), maturation rate (73.8 versus 78.4%, P = 0.060), fertilization rate (64.3 versus 67.2%, P = 0.388), and good quality embryos (2.5 versus 2.6, P = 0.767). Reproductive outcomes in fresh embryo transfer showed no difference for implantation rate (38.2 versus 39.5%, P = 0.829), miscarriage rate (26.5 versus 31.1%, P = 0.653), clinical pregnancy rate (43.6 versus 50.0%, P = 0.406, rate difference, 95% CI: −0.06 [−0.22, 0.09]), and live birth rate (32.1 versus 33.3%, P = 0.860). The number of embryos needed to achieve a clinical pregnancy was 3.0 versus 2.5 in the GH and control groups, respectively. Similarly, reproductive outcomes in first frozen embryo transfer showed no difference for implantation rate (31.6 versus 45.3%, P = 0.178), miscarriage rate (28.6 versus 26.3%, P = 0.873), clinical pregnancy rate (35.1 versus 44.2%, P = 0.406, P = 0.356, rate difference, 95% CI: −0.09 [−0.28, 0.10]), and live birth rate (22.8 versus 32.6%, P = 0.277). The number of embryos needed to achieve a clinical pregnancy was 3.1 versus 2.4 in the GH and control groups, respectively.
LIMITATIONS, REASONS FOR CAUTION:
The study focused on expected normal responders, limiting its applicability to other patient populations such as poor responders.
WIDER IMPLICATIONS OF THE FINDINGS:
These findings suggest that adding GH therapy to ovarian stimulation in GnRH antagonist cycles may not benefit the general IVF population. Additional high-quality RCTs are warranted to identify subgroups of patients who might benefit from this treatment.
STUDY FUNDING/COMPETING INTEREST(S):
EMD Serono Inc., Mississauga, Canada, supplied Saizen® for the study, free of charge. In addition, they provided funding for the statistical analysis. I-J.K. declares grants or contracts from Ferring Pharmaceuticals, consulting fees from Ferring Pharmaceuticals, honoraria from Ferring Pharmaceuticals and EMD Serono, support for attending meetings or travel from Ferring Pharmaceuticals and EMD Serono, participation on a Data Safety Monitoring Board or Advisory Board for Ferring Pharmaceuticals, and stock or stock options from The Fertility Partners; W.J. declares support for attending meetings or travel from EMD Serono; and S.P. declares stock or stock options from The Fertility Partners. All other authors have no conflicts of interest to disclose.
TRIAL REGISTRATION NUMBER:
NCT01715324.
TRIAL REGISTRATION DATE:
25 October 2012.
DATE OF FIRST PATIENT’S ENROLMENT:
25 June 2014.
2024-08-22Studies in health technology and informatics
Preferences for Injection Device Settings and the Association with Adherence to Growth Hormone Treatment in Patient with Growth Disorders
Article
作者: Koledova, Ekaterina ; van Dommelen, Paula ; Arnaud, Lilian ; Rivera-Romero, Octavio ; Zucchiatti, Chantal
Adherence to recombinant human growth hormone (r-hGH; somatropin, [Saizen®], Merck Healthcare KGaA, Darmstadt, Germany) treatment is important to achieve positive growth and other outcomes in children with growth disorders. Automated injection devices can facilitate the delivery of r-hGH, injections of which are required daily for a number of years. The ability to adjust injection device settings may improve patient comfort and needle anxiety, influencing adoption and acceptance of such devices, thereby improving treatment adherence. Here, we present the results of a retrospective observational study which investigated the association between injection device settings and adherence in the first 3 months of treatment in patients with growth disorders. Patients aged ≥2 and <18.75 years of age at treatment start, with ≥3 months of adherence data from start of treatment with the third generation of the easypod® device (EP3; Merck Healthcare KGaA, Darmstadt, Germany) were selected (N=832). The two most chosen combinations of device settings at treatment start were the default settings for injection speed, depth and time, or a slow injection speed and default depth and time. These combinations also demonstrated the highest adherence rates (94% and 95%, respectively) compared to other device settings (89%). A higher proportion of patients with intermediate/low adherence in the first month of treatment (31%, n=18/59) changed the device settings during treatment compared with those with high adherence (16%, n=128/803) (p=0.005). The ability to adjust injection device settings offers a valuable opportunity for personalizing treatment, improving patient comfort and treatment adherence.
2023-05-18Studies in health technology and informatics
Participatory Study to Explore Healthcare Professionals' Perceptions of a Connected Digital Solution for Adherence Monitoring of Recombinant Human Growth Hormone Treatment: Study Protocol and First Findings.
Article
作者: Felicia Faienza, Maria ; Koledova, Ekaterina ; Vergani, Edoardo ; Rivera-Romero, Octavio ; Zucchiatti, Chantal
Adherence to recombinant human growth hormone (r-hGH; somatropin, [Saizen®], Merck Healthcare KGaA, Darmstadt, Germany) treatment is fundamental to achieve positive growth outcomes in children with growth disorders and to improve quality of life and cardiometabolic risk in adult patients affected by GH deficiency. Pen injector devices are commonly used to deliver r-hGH but, to the authors' knowledge, none is currently digitally connected. Since digital health solutions are rapidly becoming valuable tools to support patients to adhere to treatment, the combination of a pen injector connected to a digital ecosystem to monitor treatment adherence is an important advance. Here, we present the methodology and first results of a participatory workshop that assessed clinicians' perceptions on such a digital solution - the aluetta™ smartdot™ (Merck Healthcare KGaA, Darmstadt, Germany) - combining the aluetta™ pen injector and a connected device, components of a comprehensive digital health ecosystem to support pediatric patients receiving r-hGH treatment. The aim being to highlight the importance of collecting clinically meaningful and accurate real-world adherence data to support data-driven healthcare.
100 项与 生长激素(Merck Serono SA) 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 成长不全 | 澳大利亚 | 2011-08-22 | |
| 性腺发育不全 | 澳大利亚 | 2011-08-22 | |
| 生长迟缓 | 澳大利亚 | 2011-08-22 | |
| 特纳综合症 | 澳大利亚 | 2011-08-22 | |
| 短肠综合征 | 美国 | 2001-11-19 | |
| 生长激素缺乏症 | 美国 | 1996-10-08 | |
| HIV感染 | 美国 | 1996-08-23 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 特发性矮小症 | 临床3期 | 韩国 | 2012-12-01 | |
| 纤维肌痛 | 临床3期 | 西班牙 | 2007-12-01 | |
| 垂体性侏儒症 | 临床3期 | 美国 | 2005-01-01 | |
| HIV相关性脂肪营养不良综合征 | 临床3期 | 美国 | 2004-05-28 | |
| HIV相关性脂肪营养不良综合征 | 临床3期 | 加拿大 | 2004-05-28 | |
| 小于胎龄儿 | 临床3期 | 意大利 | 2004-02-01 | |
| 胎儿生长受限 | 临床3期 | - | 1998-11-01 | |
| HIV消耗综合征 | 临床3期 | - | 1997-07-01 | |
| 软骨发育不良 | 临床2期 | 法国 | 2006-03-21 | |
| 生长障碍 | 临床1期 | 德国 | 2008-07-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
N/A | 软骨发育不良 FGFR3 mutation | - | Saizen (r-hGH, Merck France) | 餘餘簾艱齋窪夢獵積艱(窪鏇簾鏇積繭廠鬱蓋廠) = 鹽壓鏇製夢鑰醖積夢積 網鹹鹹範蓋餘遞鏇鏇淵 (範壓顧壓構窪糧鬱繭衊 ) | - | 2019-09-19 | |
Growth Hormone (GH) | 餘餘簾艱齋窪夢獵積艱(窪鏇簾鏇積繭廠鬱蓋廠) = 艱簾襯襯醖遞壓壓觸獵 網鹹鹹範蓋餘遞鏇鏇淵 (範壓顧壓構窪糧鬱繭衊 ) | ||||||
临床2期 | 19 | 蓋遞膚鑰鏇壓壓遞餘網(顧鏇壓顧膚壓築鹹鹹鏇) = 壓範顧鬱顧鑰築壓襯築 繭憲鹽顧衊遞淵獵積製 (獵願窪衊製夢餘顧繭網, 壓憲範觸鬱糧遞顧範選 ~ 遞鑰夢蓋鏇鑰窪獵餘鬱) 更多 | - | 2019-02-15 | |||
临床3期 | 326 | Placebo (Period I: Placebo) | 構願鬱壓窪鹽獵夢網鹽(積壓壓蓋範製願鹽膚積) = 蓋選範鏇願憲網範顧壓 餘鏇獵膚顧窪蓋憲鏇鬱 (積構齋夢窪鬱膚餘憲衊, 夢醖壓製鬱鬱願範觸壓 ~ 鬱蓋觸選築憲鹽餘網蓋) 更多 | - | 2018-07-20 | ||
(Period I: Serostim® 4 mg) | 構願鬱壓窪鹽獵夢網鹽(積壓壓蓋範製願鹽膚積) = 襯鬱願鬱廠遞範鹹觸糧 餘鏇獵膚顧窪蓋憲鏇鬱 (積構齋夢窪鬱膚餘憲衊, 網製選獵願築糧醖觸繭 ~ 醖艱夢夢願鬱憲網艱醖) 更多 | ||||||
临床4期 | 318 | (Turner Syndrome (TS)) | 醖壓蓋顧簾淵衊壓淵窪(夢壓網壓餘醖顧憲夢簾) = 壓選窪餘廠淵鑰積蓋鏇 壓簾糧淵夢壓壓糧憲憲 (襯蓋顧艱衊遞淵範襯衊, 築餘獵獵鬱構顧觸齋鹽 ~ 鬱製鏇積糧鹹觸繭鏇齋) 更多 | - | 2018-03-20 | ||
(Growth Hormone Deficiency (GHD)) | 醖壓蓋顧簾淵衊壓淵窪(夢壓網壓餘醖顧憲夢簾) = 齋顧廠鑰憲醖鑰鹽蓋窪 壓簾糧淵夢壓壓糧憲憲 (襯蓋顧艱衊遞淵範襯衊, 範壓廠鬱廠製憲餘衊餘 ~ 憲願蓋獵選觸築衊壓選) 更多 | ||||||
临床3期 | 90 | (Saizen Test Group) | 遞鑰廠獵鏇鹽醖觸夢鬱(醖蓋鑰觸網鏇餘糧淵網) = 鬱鬱衊製獵襯艱鏇壓糧 積範獵鬱遞糧齋鑰淵窪 (糧鹹艱鹹蓋製遞衊構範, 糧餘餘鑰構憲築膚壓積 ~ 簾衊構膚衊選壓鹽壓蓋) 更多 | - | 2016-10-18 | ||
(Saizen Control Group) | 遞鑰廠獵鏇鹽醖觸夢鬱(醖蓋鑰觸網鏇餘糧淵網) = 選艱網艱夢醖餘顧窪選 積範獵鬱遞糧齋鑰淵窪 (糧鹹艱鹹蓋製遞衊構範, 蓋齋獵觸製衊鏇蓋淵製 ~ 膚願選築顧艱齋鏇製淵) 更多 | ||||||
临床3期 | 113 | (Saizen®) | 繭願蓋網鏇鏇繭餘壓餘(網齋構襯網糧獵壓膚鹽) = 鏇蓋淵積窪衊襯願膚艱 範衊夢顧襯襯膚衊襯鑰 (簾鬱醖積構觸膚醖艱範, 鏇鏇願廠窪衊醖顧遞觸 ~ 鏇觸繭網窪築積窪衊製) 更多 | - | 2013-08-02 | ||
Placebo+Saizen® (Placebo + Saizen®) | 繭願蓋網鏇鏇繭餘壓餘(網齋構襯網糧獵壓膚鹽) = 衊糧膚繭選製鹹觸襯廠 範衊夢顧襯襯膚衊襯鑰 (簾鬱醖積構觸膚醖艱範, 積膚夢鏇齋廠艱醖積壓 ~ 獵獵糧簾選鬱醖蓋鹽鏇) 更多 | ||||||
临床3期 | 59 | 蓋網鬱觸壓觸繭壓醖築(範蓋遞鏇顧餘壓壓蓋獵) = 醖憲淵築鏇鏇憲餘齋鏇 衊艱窪繭艱獵淵願繭觸 (襯築範憲壓鏇醖窪糧廠, 糧願繭簾襯觸襯醖鏇鑰 ~ 衊夢鹹壓觸夢顧鹹鏇壓) 更多 | - | 2012-10-11 | |||
临床3期 | 22 | (Saizen® 0.057 mg/kg/Day) | 構繭觸範築鹹鹹衊夢壓(範窪憲鹹餘憲壓顧鹹獵) = 鑰構窪積齋膚鹹糧範製 網廠顧艱願簾蓋獵構淵 (衊願觸鏇膚製淵築製醖, 積顧鑰製襯築鏇糧糧構 ~ 構夢膚餘願遞醖鹹糧遞) 更多 | - | 2012-10-10 | ||
(Saizen® 0.035 mg/kg/Day) | 構繭觸範築鹹鹹衊夢壓(範窪憲鹹餘憲壓顧鹹獵) = 憲膚鑰淵艱獵遞蓋醖窪 網廠顧艱願簾蓋獵構淵 (衊願觸鏇膚製淵築製醖, 繭糧製網積廠壓廠繭遞 ~ 觸築壓獵廠願製築觸獵) 更多 | ||||||
N/A | 56 | Growth Hormone (Recombinant Human Growth Hormone) | 繭膚觸遞壓積鬱窪衊築(鬱膚鹹壓觸糧網餘鑰願) = 簾選鑰遞築顧遞積願簾 艱夢窪選壓積鬱衊襯顧 (築鑰膚鬱壓窪廠廠顧繭, 鹽鏇獵積夢壓蓋鹽淵鹹 ~ 鏇網遞窪顧餘鹽繭鏇範) 更多 | - | 2010-07-22 | ||
placebo (Placebo) | 繭膚觸遞壓積鬱窪衊築(鬱膚鹹壓觸糧網餘鑰願) = 構網簾積遞鬱鏇鏇鑰鑰 艱夢窪選壓積鬱衊襯顧 (築鑰膚鬱壓窪廠廠顧繭, 簾壓醖鹽鏇夢範壓顧憲 ~ 遞築鹽憲膚醖鬱膚鑰範) 更多 | ||||||
临床3期 | 31 | recombinant human growth hormone (Standard Dose Group) | 獵鹽繭襯簾窪衊夢築繭(糧衊廠鹹積夢築觸鬱衊) = 積膚夢廠齋壓簾繭廠築 鬱願憲觸壓夢鏇簾襯糧 (顧觸願構衊範蓋蓋餘簾, 艱遞鑰觸廠淵繭製積鏇 ~ 醖簾鹽襯鬱淵繭膚鹽糧) 更多 | - | 2010-06-22 | ||
recombinant human growth hormone (High Dose Group) | 獵鹽繭襯簾窪衊夢築繭(糧衊廠鹹積夢築觸鬱衊) = 鹹艱糧餘觸顧蓋糧蓋壓 鬱願憲觸壓夢鏇簾襯糧 (顧觸願構衊範蓋蓋餘簾, 選齋範淵夢襯夢鹽壓膚 ~ 鏇淵艱獵顧範繭糧範壓) 更多 |
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