GB06 Phase III Trial for Pediatric Growth Hormone Deficiency

Exclusion Criteria23

• Known allergy to ingredients of the study drug;
• Previous treatment with recombinant human growth hormone (rhGH) or IGF-1 or combination with other treatments that may affect growth;
• Administration of any investigational drug within 3 months before screening or participation in another clinical trial before randomization;
• Small for gestational age;
• Epiphyseal closure;
• Congenital intracranial hypertension;
• Slipped capital femoral epiphysis;
• GHD secondary to another pituitary hormone deficiency;
• Previous history or current diagnosis of malignancy (including intracranial tumors); Intracranial tumors must be confirmed by magnetic resonance imaging or computed tomography;
• History of fundus lesions (optic nerve papilledema lesions);
• Diagnosis of diabetes, or fasting blood glucose ≥ 7.0 mmol/L or hemoglobin A1c (HbA1c) ≥ 6.5%;
• Administration of systemic corticosteroid therapy consecutively for more than 2 weeks within 3 months before screening;
• Expected requirement to inhale budesonide >400μg/day or equivalent dose of inhaled glucocorticoid therapy for more than four consecutive weeks during the trial;
• Other growth abnormalities or abnormalities that may affect height, including but not limited to: chromosomal aneuploidy, Turner syndrome, Lehren's syndrome, Noonan syndrome, Prader-Willi syndrome, SHOX-1 gene abnormality, GH receptor deletion, or other significant genetic mutations causing short stature; Significant spinal abnormalities, including but not limited to scoliosis, kyphosis, and spina bifida; Congenital anomalies (resulting in skeletal abnormalities), including but not limited to Russell-Silver syndrome and bone dysplasia; Family history of bone dysplasia;
• Other clinically significant abnormalities that may affect growth or assessment of growth capacity, including but not limited to hepatic and renal dysfunction \[e.g., alanine aminotransferase (ALT)> 1.5 times the upper limit of normal, creatinine (Cr) >upper limit of normal value\], malnutrition, severe cardiopulmonary and hematological diseases, systemic infection, immunodeficiency, mental abnormalities, and other congenital malformations;
• Infectious diseases, such as hepatitis B, hepatitis C, AIDS, syphilis, and tuberculosis. Hepatitis B virus DNA levels will be assessed in individuals who are positive for HBV surface antigen.
• A hepatitis C virus RNA test is required if the hepatitis C virus antibody test is positive. Quantitative results below the lower limit of detection will be excluded.
• Concomitant use of other treatments that may affect growth, including but not limited to methylphenidate for attention deficit hyperactivity disorder;
• History of drug or alcohol abuse;
• Children with hypothyroidism and/or adrenal insufficiency who have not received adequate stable replacement therapy lasting at least 90 days before randomization;
• Other diseases that the investigator believes may endanger the safety of the participant or protocol compliance;
• Potentially poor compliance in this study.
• Other conditions that the investigator deems unsuitable for inclusion.