Jin Soon Hwang1, Hae Sang Lee1, Kee-Hyoung Lee2, Han-Wook Yoo3, Dae-Yeol Lee4, Byung-Kyu Suh5, Cheol Woo Ko6, Woo Yeong Chung7, Dong-Kyu Jin8, Choong Ho Shin9, Heon-Seok Han10, Song Han11, Ho-Seong Kim12. 1. Department of Pediatrics, Ajou University School of Medicine, Suwon, Republic of Korea. 2. Department of Pediatrics, College of Medicine, Korea University, Seoul, Republic of Korea. 3. Asan Medical Center Children's Hospital, University of Ulsan College of Medicine, Seoul, Republic of Korea. 4. Department of Pediatrics, Chonbuk National University Medical School, Research Institute of Clinical Medicine, Jeonju, Republic of Korea. 5. Department of Pediatrics, College of Medicine, Seoul Saint Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea. 6. Department of Pediatrics, School of Medicine, Kyungpook National University, Daegu, Republic of Korea. 7. Department of Pediatrics, College of Medicine, Inje University, Busan, Republic of Korea. 8. Department of Pediatrics, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Republic of Korea. 9. Department of Pediatrics, College of Medicine, Seoul National University, Seoul, Republic of Korea. 10. Department of Pediatrics, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Republic of Korea. 11. LG Chem, Ltd., Seoul, Republic of Korea. 12. Department of Pediatrics, Institute of Endocrinology, College of Medicine Yonsei University, Seoul, Republic of Korea.
Abstract
BACKGROUND/AIMS: To determine the optimal dose of LB03002, a sustained-release, once-weekly formulation of recombinant human growth hormone (rhGH), and to compare its efficacy and safety with daily rhGH in children with idiopathic short stature (ISS). METHODS: This multicenter, randomized, open-label, phase II study included GH-naïve, prepubertal children with ISS, randomized to receive daily rhGH 0.37 mg/kg/week (control, n = 16), LB03002 0.5 mg/kg/week (n = 14), or LB03002 0.7 mg/kg/week (n = 16). The primary endpoint was height velocity (HV) change at week 26. RESULTS: At week 26, the least square (LS) means for HV change (cm/year) with control, LB03002 0.5 mg/kg/week, and LB03002 0.7 mg/kg/week were 5.08, 3.65, and 4.38, and the LS means for the change in height standard deviation score were 0.65, 0.49, and 0.58, respectively. The lower bound of the 90% confidence interval for the difference between LB03002 0.7 mg/kg/week and the control in the LS mean for HV change (-1.72) satisfied the noninferiority margin (-1.75). Adverse events were generally mild and short-lived. CONCLUSION: A once-weekly regimen of LB03002 0.7 mg/kg demonstrated noninferiority to the daily regimen of rhGH 0.37 mg/kg/week in terms of HV increments. LB03002 was well tolerated and its safety profile was comparable with that of daily rhGH. The Author(s). Published by S. Karger AG, Basel.
RCT Entities:
BACKGROUND/AIMS: To determine the optimal dose of LB03002, a sustained-release, once-weekly formulation of recombinant humangrowth hormone (rhGH), and to compare its efficacy and safety with daily rhGH in children with idiopathic short stature (ISS). METHODS: This multicenter, randomized, open-label, phase II study included GH-naïve, prepubertal children with ISS, randomized to receive daily rhGH 0.37 mg/kg/week (control, n = 16), LB03002 0.5 mg/kg/week (n = 14), or LB03002 0.7 mg/kg/week (n = 16). The primary endpoint was height velocity (HV) change at week 26. RESULTS: At week 26, the least square (LS) means for HV change (cm/year) with control, LB03002 0.5 mg/kg/week, and LB03002 0.7 mg/kg/week were 5.08, 3.65, and 4.38, and the LS means for the change in height standard deviation score were 0.65, 0.49, and 0.58, respectively. The lower bound of the 90% confidence interval for the difference between LB03002 0.7 mg/kg/week and the control in the LS mean for HV change (-1.72) satisfied the noninferiority margin (-1.75). Adverse events were generally mild and short-lived. CONCLUSION: A once-weekly regimen of LB03002 0.7 mg/kg demonstrated noninferiority to the daily regimen of rhGH 0.37 mg/kg/week in terms of HV increments. LB03002 was well tolerated and its safety profile was comparable with that of daily rhGH. The Author(s). Published by S. Karger AG, Basel.
Entities:
Keywords:
Height velocity; Idiopathic short stature ; Sustained-release growth hormone
Authors: Sei Eun Hyun; Byung Churl Lee; Byung Kyu Suh; So Chung Chung; Cheol Woo Ko; Heung Sik Kim; Kee Hyoung Lee; Sei Won Yang; Choong Ho Shin; Jin Soon Hwang; Duk Hee Kim; Baek Keun Lim; Jong Duck Kim; Han-Wook Yoo; Hye Soon Kim; Woo Yeong Chung; Mi Jung Park; Young Jong Woo; Chan Jong Kim; Dae-Yeol Lee; Eun Young Kim; Jin Ho Choi; Heon Seok Han; Il Tae Hwang; Ho-Seong Kim Journal: Clin Biochem Date: 2011-10-12 Impact factor: 3.281
Authors: Kevin C J Yuen; Bradley S Miller; Cesar L Boguszewski; Andrew R Hoffman Journal: Front Endocrinol (Lausanne) Date: 2021-02-24 Impact factor: 5.555