A Multicenter, Randomized, Open-Label, Positive-Controlled Phase III Clinical Trial to Study the Efficacy and Safety of Human Growth Hormone Injection (GB06) in Treating Growth Disorders Caused by Pediatric Growth Hormone Deficiency
This study aims to evaluate the efficacy and safety of GB06 (a biosimilar of Norditropin®FlexProTM from Novo Nordisk) for the treatment of growth disorders caused by growth hormone deficiency (GHD) in children. It aims to determine whether the annual height velocity (an index of height growth rate) in children diagnosed with GHD after 52 weeks of GB06 intervention is comparable to that of Norditropin®FlexProTM. To achieve this, the participants will administer GB06 or Norditropin®FlexProTM at 0.035mg/kg/day for 52 consecutive weeks.
• The legal guardian of the participant understands and signs the written informed consent form (ICF); Participants over 8 years old are also required to sign the ICF, and if they are under 8 years old but can express consent, their opinions should be clearly documented.
• Age ≥ 3 years old and ≤ 11 years old (boys) or ≤ 10 years old (girls);
• Height below two standard deviations (SD) of the average height of children of the same age and gender;
• Annual height velocity (AHV) \<5cm/year, based on height within 6 months to 18 months before screening;
• Body mass index (BMI) within the average ±2 SD of healthy children of the same age and gender;
• Short stature with normal intellectual development;
• Tanner stage I (testicular volume \<4ml for boys, no palpable breast gland tissue for girls);
• IGF-1 level below the reference value corresponding to -1SDS for children of the same age and gender;
• Bone age lags behind the chronological age;
⁃ Diagnosis as GHD by GH stimulation test with two different drugs within 12 months before screening, and the peak GH level ≤ 10.0ng/ml;
⁃ A standard karyotype of 46, XX for girls.