Woo Yeong Chung1, Han-Wook Yoo2, Jin Soon Hwang3, Cheol Woo Ko4, Ho-Seong Kim5, Dong-Kyu Jin6, Kee-Hyoung Lee7, Heon-Seok Han8, Premila Paranchothy9, Byung-Kyu Suh10. 1. Department of Pediatrics, Inje University Busan Paik Hospital, Busan, Republic of Korea. 2. Department of Pediatrics, Asan Medical Centre, University of Ulsan College of Medicine, Seoul, Republic of Korea. 3. Department of Pediatrics, Ajou University Hospital, Ajou University School of Medicine, Suwon, Republic of Korea. 4. Department of Pediatrics, Kyungpook National University Hospital, Kyungpook National University School of Medicine, Daegu, Republic of Korea. 5. Department of Pediatrics, Severance Children's Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea. 6. Department of Pediatrics, Samsung Medical Centre, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. 7. Department of Pediatrics, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea. 8. Department of Pediatrics, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Republic of Korea. 9. Merck Ltd, Korea, Seoul, Republic of Korea. 10. Department of Pediatrics, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
Abstract
BACKGROUND/AIMS: The SYNERGY (Saizen®for Your New Life and Brighter Tomorrow without Growth Deficiency) study is the first randomised multi-centre, open-label study to assess the short-term efficacy and safety of this recombinant human growth hormone (r-hGH) preparation for prepubertal children with idiopathic short stature in South Korea. METHODS: The SYNERGY study (ClinicalTrials.gov NCT01746862) was conducted at 9 centres throughout South Korea between December 2012 and March 2015. The primary endpoint was difference in height velocity from baseline to 6 months in the treatment and control arms. RESULTS:97 children were screened; 90 were randomly assigned: 60 children to 0.067 mg/kg/day r-hGH for 12 months (treatment) and 30 children to 6 months of no treatment followed by 0.067 mg/kg/day r-hGH for 6 months (control). The 6-month mean height velocity in the treatment group increased from 5.63 cm/year (SD 1.62) to 10.08 cm/year (SD 1.92) (p < 0.0001) and from 4.94 cm/year (SD 1.91) to 5.92 cm/year (SD 2.01) (p = 0.0938) in the control group (between-group difference 3.47 cm/year, 95% CI 2.17-4.78; p < 0.0001). Adherence was > 90% throughout the study. The safety profile was consistent with that already known for r-hGH. CONCLUSION: Treatment with r-hGH in the SYNERGY study demonstrated a statistically significant increase in height velocity at 6 months.
RCT Entities:
BACKGROUND/AIMS: The SYNERGY (Saizen® for Your New Life and Brighter Tomorrow without Growth Deficiency) study is the first randomised multi-centre, open-label study to assess the short-term efficacy and safety of this recombinant humangrowth hormone (r-hGH) preparation for prepubertal children with idiopathic short stature in South Korea. METHODS: The SYNERGY study (ClinicalTrials.gov NCT01746862) was conducted at 9 centres throughout South Korea between December 2012 and March 2015. The primary endpoint was difference in height velocity from baseline to 6 months in the treatment and control arms. RESULTS: 97 children were screened; 90 were randomly assigned: 60 children to 0.067 mg/kg/day r-hGH for 12 months (treatment) and 30 children to 6 months of no treatment followed by 0.067 mg/kg/day r-hGH for 6 months (control). The 6-month mean height velocity in the treatment group increased from 5.63 cm/year (SD 1.62) to 10.08 cm/year (SD 1.92) (p < 0.0001) and from 4.94 cm/year (SD 1.91) to 5.92 cm/year (SD 2.01) (p = 0.0938) in the control group (between-group difference 3.47 cm/year, 95% CI 2.17-4.78; p < 0.0001). Adherence was > 90% throughout the study. The safety profile was consistent with that already known for r-hGH. CONCLUSION: Treatment with r-hGH in the SYNERGY study demonstrated a statistically significant increase in height velocity at 6 months.
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