Reduced Effectiveness and Comparable Safety in Biweekly vs. Weekly PEGylated Recombinant Human Growth Hormone for Children With Growth Hormone Deficiency: A Phase IV Non-Inferiority Threshold Targeted Trial (vol 12, 779365, 2021)

被引：0

作者：

Sun, Chengjun ^{[1
]}

Lu, Biao ^{[2
]}

Liu, Yu ^{[3
]}

Zhang, Yaqin ^{[4
]}

Wei, Haiyan ^{[5
]}

Hu, Xu ^{[6
]}

Hu, Pei ^{[7
]}

Zhao, Qian ^{[7
]}

Liu, Yanling ^{[8
]}

Ye, Kan ^{[9
]}

Wang, Kan ^{[10
]}

Gu, Zaiyan ^{[11
]}

Liu, Zheng ^{[12
]}

Ye, Jin ^{[13
]}

Zhang, Hongxiao ^{[14
]}

Zhu, Hong ^{[15
]}

Jiang, Zhihong ^{[16
]}

Liu, Yanjie ^{[17
]}

Wan, Naijun ^{[18
]}

Yan, Chengming ^{[19
]}

Yin, Jianying ^{[20
]}

Ying, Lirong ^{[21
]}

Huang, Feng ^{[22
]}

Yin, Qingjin ^{[23
]}

Xi, Li ^{[1
]}

Luo, Feihong ^{[1
]}

Cheng, Ruoqian ^{[1
]}

机构：

[1] Fudan Univ, Childrens Hosp, Dept Pediat Endocrinol & Inherited Metab Dis, Shanghai, Peoples R China

[2] Ningxia Med Univ, Dept Pediat, Gen Hosp, Yinchuan, Ningxia, Peoples R China

[3] Maternal & Child Health Care Hosp Guiyang, Dept Endocrine & Genet Metab, Guiyang, Peoples R China

[4] Maternal & Child Hlth Care Hosp Hainan Prov, Dept Child Hlth, Haikou, Hainan, Peoples R China

[5] Zhengzhou Univ, Henan Prov Hosp, Dept Pediat Endocrinol & Inherited Metab Dis, Zhengzhou, Peoples R China

[6] Luan Peoples Hosp, Dept Pediat, Luan, Peoples R China

[7] Chinese Acad Med Sci & Peking Union Med Coll, Clin Pharmacol Res Ctr,State Key Lab Complex Seve, Peking Union Med Coll Hosp,Natl Med Prod Adm NMPA, Beijing Key Lab Clin Pharmacokinet & Pharmacodyna, Beijing, Peoples R China

[8] Nanchang Univ, Dept Pediat, Affiliated Hosp 2, Nanchang, Jiangxi, Peoples R China

[9] Nanjing Med Univ, Dept Child Hlth, Affiliated Suzhou Hosp, Suzhou, Peoples R China

[10] Zhejiang Univ, Jinhua Hosp, Dept Pediat, Sch Med, Jinhua, Peoples R China

[11] Jiaxing First Hosp, Dept Pediat, Jiaxing, Peoples R China

[12] Taian Maternal & Child Hlth Care Hosp, Dept Pediat, Tai An, Shandong, Peoples R China

[13] Jiangsu Prov Hosp Chinese Med, Dept Pediat, Nanjing, Peoples R China

[14] Lanzhou Univ, Dept Pediat, Hosp 2, Lanzhou, Peoples R China

[15] First Peoples Hosp Changzhou, Dept Pediat, Changzhou, Peoples R China

[16] Henan Univ Sci & Technol, Dept Pediat, Affiliated Hosp 1, Luoyang, Peoples R China

[17] Inner Mongolia Peoples Hosp, Dept Pediat, Hohhot, Peoples R China

[18] Jishuitan Hosp, Dept Pediat, Beijing, Peoples R China

[19] Anhui Med Univ, Maternal & Child Hlth Clin Coll, Dept Pediat, Anhui Prov Matern & Child Hlth Hosp, Hefei, Peoples R China

[20] Hebei Gen Hosp, Dept Pediat, Shijiazhuang, Hebei, Peoples R China

[21] Cixi Peoples Hosp, Dept Pediat, Cixi, Peoples R China

[22] Nantong Univ, Dept Pediat, Affiliated Hosp, Nantong, Peoples R China

[23] Chengdu Childrens Specialized Hosp, Dept Internal Med, Chengdu, Peoples R China

来源：

FRONTIERS IN ENDOCRINOLOGY | 2021年 / 12卷

关键词：

growth hormone deficiency; PEGylated recombinant human growth hormone; PEG-rhGH; IGF-2; children;

D O I：

10.3389/fendo.2021.830469

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

引用

页数：2

共 3 条

[1] Reduced Effectiveness and Comparable Safety in Biweekly vs. Weekly PEGylated Recombinant Human Growth Hormone for Children With Growth Hormone Deficiency: A Phase IV Non-Inferiority Threshold Targeted Trial
Sun, Chengjun
Lu, Biao
Liu, Yu
Zhang, Yaqin
Wei, Haiyan
Hu, Xu
Hu, Pei
Zhao, Qian
Liu, Yanling
Ye, Kan
Wang, Kan
Gu, Zaiyan
Liu, Zheng
Ye, Jin
Zhang, Hongxiao
Zhu, Hong
Jiang, Zhihong
Liu, Yanjie
Wan, Naijun
Yan, Chengming
Yin, Jianying
Ying, Lirong
Huang, Feng
Yin, Qingjin
Xi, Li
Luo, Feihong
Cheng, Ruoqian
FRONTIERS IN ENDOCRINOLOGY, 2021, 12
[2] Evaluation of the safety and efficacy of biosimilar recombinant growth hormone in children with growth hormone deficiency: non-inferiority, randomized, parallel, multicentric and Phase III trial
Zaeri, Hossein
Omidvar, Shahriar
Servatian, Nazli
Arefnia, Serajaddin
Khademolreza, Nasrin
Amini, Hossein
Taghavi, Behnam
Hashemipour, Mahin
Eshraghi, Peyman
Ghasemi, Mahmoud
Ghergherehchi, Robabeh
Maleki, Elham
Moravej, Hossein
Noorian, Shahab
Soheilipour, Fahimeh
Dalili, Setila
Kharazmi, Hosseinali
Didban, Abdollah
Akhlaghi, Aliasghar
Ghaznavi, Sina
Shahbazi, Majid
EXPERT OPINION ON DRUG SAFETY, 2025, 24 (01) : 111 - 119
[3] Efficacy and safety of a biosimilar recombinant human growth hormone (r-hGH Cristalia) compared with reference r-hGH in children with growth hormone deficiency (CERES study): A randomized, multicentric, investigator-blind, phase 3 trial
Czepielewski, M. A.
Garret, Q.
Vencio, S. A. C.
Rassi, N.
Felicio, J. S.
Faria, M. S.
Senn, C. C. P.
Bronstein, M. D.
Cerqueira, M. J. A. G.
Neves, A. C. L.
Sgarbi, J. A.
Spinola-Castro, A. M.
Cunha, M. P. R.
Bandeira, F.
Toffoletto, O.
Afiune, J.
Baradelli, R.
Rodrigues, D. G.
Scharf, M.
GROWTH HORMONE & IGF RESEARCH, 2019, 48-49 : 29 - 35

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