A multicenter, randomized, open-label, positive-controlled Phase III clinical study on the efficacy and safety of recombinant human growth hormone injection (GB06) in treating growth disorders caused by growth hormone deficiency in children

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: Test group:Study drug GB06;Control group:Norditropin? FlexPro?; CONDITION: Growth disorder caused by insufficient growth hormone secretion in children PRIMARY OUTCOME: AHV; SECONDARY OUTCOME: Chronological age (CA) height SDS (Ht SDS CA) and its change from baseline;Bone age (BA) and its change from baseline;All observed adverse events, including abnormal clinical symptoms and vital signs, administration site examinations, laboratory and imaging examinations (including but not limited to fasting blood glu;Tanner staging and its change from baseline;Anti?drug antibody (ADA) and neutralizing antibody (NAb);BA/CA and its change from baseline;IGF‐1 and IGF‐1 SDS, along with their changes from baseline.;Height SDS by bone age (Ht SDS BA) and its change from baseline.;IGFBP‐3 and IGFBP‐3 SDS, and their changes from baseline.;Annualized Height Velocity (AHV) standard deviation score (SDS) and its change from baseline.; INCLUSION CRITERIA: 1. The guardian understands and signs the written informed consent form (ICF); participants aged 8 years or older also need to sign the ICF, and for those under 8 years who can express consent, their opinions should be explicitly recorded; 2. Age at signing the informed consent form >= 3 years, with boys <= 11 years and girls <= 10 years; 3. Height at screening is below 2 standard deviations (SD) of the average height for healthy children of the same age and se X(see Attachment 1); 4. Annualized height velocity (AHV) within 6 to 18 months prior to screening < 5 cm/year (referencing the 2008 Guidelines for Diagnosis and Treatment of Short Stature in Children by the Pediatrics Endocrinology and Genetics Group of the Chinese Medical Association, and Recommendations for Clinical Application of Recombinant Human Growth Hormone in Pediatrics); 5. Body mass inde X(BMI) within ±2 SD of the average for healthy children of the same age and se X(see Attachment 2);<
Epistemonikos ID: cd1af9215e8e1c492787dae5246988ceb3ba2daa
First added on: May 02, 2026