Efficacy and safety of LB03002, a once-weekly sustained-release human GH for 12-month treatment in Korean children with GH deficiency

Jin Soon Hwang, Hae Sang Lee, Woo Yeong Chung, Heon Seok Han, Dong Kyu Jin, Ho Seong Kim, Cheol Woo Ko, Byung Churl Lee, Dae Yeol Lee, Kee Hyoung Lee, Jeh Hoon Shin, Byung Kyu Suh, Han Wook Yoo, Hyi Jeong Ji, Jin Hwa Lee, Yoon Ju Bae, Duk Hee Kim, Sei Won Yang

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Purpose: The purpose of this study was to investigate the efficacy and safety of LB03002, a sustainedrelease human GH (SR-hGH), compared with that of daily rhGH for 12 months in children with GH deficiency (GHD). Methods: A total of 73 children with GHD were screened and 63 eligible subjects were randomized in a 1:1 ratio of LB03002 (SR-hGH) to daily rhGH treatment group. LB03002 was administered once weekly at a dose of 0.5 mg/kg while daily rhGH was administered for 6 consecutive days with equally divided doses to make a total of 0.21 mg/kg per week. Treatments were given for 12 months by s.c. injections. Injection site reactions and adverse events were investigated throughout the study period. Results: The mean (S.D.) height velocity (HV) showed a clinically significant increase after the 6-month treatment: 3.00 (1.15) cm/year at screening to 9.78 (1.98) cm/year at 6 months in the LB03002 group; 2.39 (1.63) cm/year at screening to 10.56 (2.65) cm/year at 6 months in the daily rhGH group. The increased HVat 12 months was still maintained in both the groups: 9.06 (1.63) cm/year at 12 months in the LB03002 group; 9.72 (2.32) cm/year at 12 months in the daily rhGH group. Most of the adverse drug reactions were mild and tolerable. No subjects were withdrawn due to adverse events. Conclusion: Weekly injection of LB03002 at a dose of 0.5 mg/kg per week was confirmed to have comparable efficacy to daily injection of rhGH at a dose of 0.21 mg/kg per week. Both formulations were well tolerated.

Original languageEnglish
Pages (from-to)179-185
Number of pages7
JournalEuropean Journal of Endocrinology
Volume169
Issue number2
DOIs
Publication statusPublished - 2013 Aug 1

Fingerprint

Safety
Injections
Therapeutics
Drug-Related Side Effects and Adverse Reactions

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Efficacy and safety of LB03002, a once-weekly sustained-release human GH for 12-month treatment in Korean children with GH deficiency. / Hwang, Jin Soon; Lee, Hae Sang; Chung, Woo Yeong; Han, Heon Seok; Jin, Dong Kyu; Kim, Ho Seong; Ko, Cheol Woo; Lee, Byung Churl; Lee, Dae Yeol; Lee, Kee Hyoung; Shin, Jeh Hoon; Suh, Byung Kyu; Yoo, Han Wook; Ji, Hyi Jeong; Lee, Jin Hwa; Bae, Yoon Ju; Kim, Duk Hee; Yang, Sei Won.

In: European Journal of Endocrinology, Vol. 169, No. 2, 01.08.2013, p. 179-185.

Research output: Contribution to journalArticle

Hwang, JS, Lee, HS, Chung, WY, Han, HS, Jin, DK, Kim, HS, Ko, CW, Lee, BC, Lee, DY, Lee, KH, Shin, JH, Suh, BK, Yoo, HW, Ji, HJ, Lee, JH, Bae, YJ, Kim, DH & Yang, SW 2013, 'Efficacy and safety of LB03002, a once-weekly sustained-release human GH for 12-month treatment in Korean children with GH deficiency', European Journal of Endocrinology, vol. 169, no. 2, pp. 179-185. https://doi.org/10.1530/EJE-13-0148
Hwang, Jin Soon ; Lee, Hae Sang ; Chung, Woo Yeong ; Han, Heon Seok ; Jin, Dong Kyu ; Kim, Ho Seong ; Ko, Cheol Woo ; Lee, Byung Churl ; Lee, Dae Yeol ; Lee, Kee Hyoung ; Shin, Jeh Hoon ; Suh, Byung Kyu ; Yoo, Han Wook ; Ji, Hyi Jeong ; Lee, Jin Hwa ; Bae, Yoon Ju ; Kim, Duk Hee ; Yang, Sei Won. / Efficacy and safety of LB03002, a once-weekly sustained-release human GH for 12-month treatment in Korean children with GH deficiency. In: European Journal of Endocrinology. 2013 ; Vol. 169, No. 2. pp. 179-185.
@article{10f15bb7ecbf40539619437c8b79177b,
title = "Efficacy and safety of LB03002, a once-weekly sustained-release human GH for 12-month treatment in Korean children with GH deficiency",
abstract = "Purpose: The purpose of this study was to investigate the efficacy and safety of LB03002, a sustainedrelease human GH (SR-hGH), compared with that of daily rhGH for 12 months in children with GH deficiency (GHD). Methods: A total of 73 children with GHD were screened and 63 eligible subjects were randomized in a 1:1 ratio of LB03002 (SR-hGH) to daily rhGH treatment group. LB03002 was administered once weekly at a dose of 0.5 mg/kg while daily rhGH was administered for 6 consecutive days with equally divided doses to make a total of 0.21 mg/kg per week. Treatments were given for 12 months by s.c. injections. Injection site reactions and adverse events were investigated throughout the study period. Results: The mean (S.D.) height velocity (HV) showed a clinically significant increase after the 6-month treatment: 3.00 (1.15) cm/year at screening to 9.78 (1.98) cm/year at 6 months in the LB03002 group; 2.39 (1.63) cm/year at screening to 10.56 (2.65) cm/year at 6 months in the daily rhGH group. The increased HVat 12 months was still maintained in both the groups: 9.06 (1.63) cm/year at 12 months in the LB03002 group; 9.72 (2.32) cm/year at 12 months in the daily rhGH group. Most of the adverse drug reactions were mild and tolerable. No subjects were withdrawn due to adverse events. Conclusion: Weekly injection of LB03002 at a dose of 0.5 mg/kg per week was confirmed to have comparable efficacy to daily injection of rhGH at a dose of 0.21 mg/kg per week. Both formulations were well tolerated.",
author = "Hwang, {Jin Soon} and Lee, {Hae Sang} and Chung, {Woo Yeong} and Han, {Heon Seok} and Jin, {Dong Kyu} and Kim, {Ho Seong} and Ko, {Cheol Woo} and Lee, {Byung Churl} and Lee, {Dae Yeol} and Lee, {Kee Hyoung} and Shin, {Jeh Hoon} and Suh, {Byung Kyu} and Yoo, {Han Wook} and Ji, {Hyi Jeong} and Lee, {Jin Hwa} and Bae, {Yoon Ju} and Kim, {Duk Hee} and Yang, {Sei Won}",
year = "2013",
month = "8",
day = "1",
doi = "10.1530/EJE-13-0148",
language = "English",
volume = "169",
pages = "179--185",
journal = "European Journal of Endocrinology",
issn = "0804-4643",
publisher = "BioScientifica Ltd.",
number = "2",

}

TY - JOUR

T1 - Efficacy and safety of LB03002, a once-weekly sustained-release human GH for 12-month treatment in Korean children with GH deficiency

AU - Hwang, Jin Soon

AU - Lee, Hae Sang

AU - Chung, Woo Yeong

AU - Han, Heon Seok

AU - Jin, Dong Kyu

AU - Kim, Ho Seong

AU - Ko, Cheol Woo

AU - Lee, Byung Churl

AU - Lee, Dae Yeol

AU - Lee, Kee Hyoung

AU - Shin, Jeh Hoon

AU - Suh, Byung Kyu

AU - Yoo, Han Wook

AU - Ji, Hyi Jeong

AU - Lee, Jin Hwa

AU - Bae, Yoon Ju

AU - Kim, Duk Hee

AU - Yang, Sei Won

PY - 2013/8/1

Y1 - 2013/8/1

N2 - Purpose: The purpose of this study was to investigate the efficacy and safety of LB03002, a sustainedrelease human GH (SR-hGH), compared with that of daily rhGH for 12 months in children with GH deficiency (GHD). Methods: A total of 73 children with GHD were screened and 63 eligible subjects were randomized in a 1:1 ratio of LB03002 (SR-hGH) to daily rhGH treatment group. LB03002 was administered once weekly at a dose of 0.5 mg/kg while daily rhGH was administered for 6 consecutive days with equally divided doses to make a total of 0.21 mg/kg per week. Treatments were given for 12 months by s.c. injections. Injection site reactions and adverse events were investigated throughout the study period. Results: The mean (S.D.) height velocity (HV) showed a clinically significant increase after the 6-month treatment: 3.00 (1.15) cm/year at screening to 9.78 (1.98) cm/year at 6 months in the LB03002 group; 2.39 (1.63) cm/year at screening to 10.56 (2.65) cm/year at 6 months in the daily rhGH group. The increased HVat 12 months was still maintained in both the groups: 9.06 (1.63) cm/year at 12 months in the LB03002 group; 9.72 (2.32) cm/year at 12 months in the daily rhGH group. Most of the adverse drug reactions were mild and tolerable. No subjects were withdrawn due to adverse events. Conclusion: Weekly injection of LB03002 at a dose of 0.5 mg/kg per week was confirmed to have comparable efficacy to daily injection of rhGH at a dose of 0.21 mg/kg per week. Both formulations were well tolerated.

AB - Purpose: The purpose of this study was to investigate the efficacy and safety of LB03002, a sustainedrelease human GH (SR-hGH), compared with that of daily rhGH for 12 months in children with GH deficiency (GHD). Methods: A total of 73 children with GHD were screened and 63 eligible subjects were randomized in a 1:1 ratio of LB03002 (SR-hGH) to daily rhGH treatment group. LB03002 was administered once weekly at a dose of 0.5 mg/kg while daily rhGH was administered for 6 consecutive days with equally divided doses to make a total of 0.21 mg/kg per week. Treatments were given for 12 months by s.c. injections. Injection site reactions and adverse events were investigated throughout the study period. Results: The mean (S.D.) height velocity (HV) showed a clinically significant increase after the 6-month treatment: 3.00 (1.15) cm/year at screening to 9.78 (1.98) cm/year at 6 months in the LB03002 group; 2.39 (1.63) cm/year at screening to 10.56 (2.65) cm/year at 6 months in the daily rhGH group. The increased HVat 12 months was still maintained in both the groups: 9.06 (1.63) cm/year at 12 months in the LB03002 group; 9.72 (2.32) cm/year at 12 months in the daily rhGH group. Most of the adverse drug reactions were mild and tolerable. No subjects were withdrawn due to adverse events. Conclusion: Weekly injection of LB03002 at a dose of 0.5 mg/kg per week was confirmed to have comparable efficacy to daily injection of rhGH at a dose of 0.21 mg/kg per week. Both formulations were well tolerated.

UR - http://www.scopus.com/inward/record.url?scp=84880963805&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84880963805&partnerID=8YFLogxK

U2 - 10.1530/EJE-13-0148

DO - 10.1530/EJE-13-0148

M3 - Article

VL - 169

SP - 179

EP - 185

JO - European Journal of Endocrinology

JF - European Journal of Endocrinology

SN - 0804-4643

IS - 2

ER -