J Korean Soc Pediatr Endocrinol.  2011 Dec;16(3):157-164. 10.6065/jkspe.2011.16.3.157.

A Single-Arm, Phase III Study to Assess Efficacy and Safety after 6-Month-Treatment of Eutropin(TM) Inj. (Recombinant Human Growth Hormone) in Prepubertal Children with Short Stature due to Small for Gestational Age

Affiliations
  • 1Department of Pediatrics, Korea University Hospital, Seoul, Korea.
  • 2Department of Pediatrics, The Catholic University St. Mary's Hospital, Seoul, Korea.
  • 3Department of Pediatrics, Kyungpook National University Hospital, Daegu, Korea.
  • 4Department of Pediatrics, Samsung Medical Center, Seoul, Korea.
  • 5Department of Pediatrics, Seoul National University Children's Hospital, Seoul, Korea.
  • 6Department of Pediatrics, Asan Medical Center, Seoul, Korea.
  • 7Department of Pediatrics, Inje University Busan Paik Hospital, Busan, Korea.
  • 8Department of Pediatrics, Severance Hospital, Seoul, Korea.
  • 9Department of Pediatrics, The Catholic University Seoul St. Mary's Hospital, Seoul, Korea. suhbk@catholic.ac.kr

Abstract

PURPOSE
Recombinant human growth hormone is an effective therapy for short-statured children born small for their gestational age (SGA). This single-arm, multicenter, phase III clinical study of such children was designed to assess the efficacy and safety of treating them with recombinant human-growth-hormone (Eutropin(TM) Inj.) for 6 months.
METHODS
Between 2005 and 2007, 30 treatment naive, prepubertal, short-statured SGA-born children were recruited as participants. Eutropin(TM) Inj. was administered for 6 months with a subcutaneous dose of 0.48 mg/kg/wk. The primary endpoint was the change in height velocity from the baseline to month 6. Various parameters were checked to obtain secondary outcome measures and to meet safety criteria.
RESULTS
Height velocity significantly increased from 5.36 +/- 1.59 cm/yr at baseline to 10.66 +/- 2.03 cm/yr at month 6 (P < 0.0001). Secondary outcome measures (height velocity at month 3, height SDS for chronological age (CA), weight SDS for CA, bone maturation, and IGF-I and IGFBP-3 levels) were also significantly increased. Eutropin(TM) Inj. was well tolerated and safe over 6 months of treatment.
CONCLUSION
The clinical efficacy and safety of Eutropin(TM) Inj. was demonstrated for the 6 month treatment of prepubertal children with short stature due to SGA. Further long-term study is needed.

Keyword

Human growth hormone; Small for gestational age; Short stature
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