Phase IV Study of rhGH Injection in Adult Short Bowel Syndrome

Exclusion Criteria18

• Subjects with a history of allergic reactions to the study drug or its analogues; subjects unsuitable for subcutaneous injection, including those receiving anticoagulant therapy, presenting with thrombocytopenia, known hemorrhagic diseases, or idiopathic thrombocytopenic purpura (ITP).
• Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and HBV DNA ≥ 1000 IU/mL within 6 months prior to screening; subjects with positive anti-HCV antibody and HCV RNA level exceeding the upper limit of normal (ULN) set by the study center.
• Subjects with a prior diagnosis of malignant tumors before screening.
• Subjects with consciousness disturbance, a history of psychiatric illness, or severe neurological dysfunction.
• Subjects with glycated hemoglobin (HbA1c) ≥ 7% at screening.
• Subjects with any of the following clinically significant cardiovascular disorders:
• History of chronic congestive heart failure with New York Heart Association (NYHA) functional class ≥ II at screening;
• Subjects who experienced myocardial infarction, acute coronary syndrome, viral myocarditis or pulmonary embolism within 6 months before screening, or underwent coronary revascularization within the preceding 6 months;
• Severe arrhythmias requiring treatment with Class Ia or Class III antiarrhythmic agents;
• Sick sinus syndrome, second-degree type II or third-degree atrioventricular block without an implanted pacemaker;
• QTc interval ≥ 470 ms for male subjects or ≥ 480 ms for female subjects at screening (calculated via the Fridericia correction formula: QTc = QT/RR⁰·³³), or a medical history of prolonged QTc interval.
• Subjects with uncontrolled hypertension: those receiving 1 to 2 oral antihypertensive drugs whose arterial blood pressure remains ≥ 160/100 mmHg on any two measurements taken within one day at screening.
• Subjects suffering from diseases requiring daily systemic glucocorticoid therapy (prednisone ≥ 10 mg/day or equivalent doses of other glucocorticoids) or immunosuppressant therapy (e.g., active inflammatory bowel disease, autoimmune disorders, radiation enteritis), and continuous treatment is expected throughout the trial period; subjects who received systemic glucocorticoids cumulatively for ≥28 days or consecutively for ≥14 days within 3 months prior to screening.
• Subjects who have received stem cell therapy, any form of bone marrow transplantation, or solid organ transplantation.
• Subjects whose abdominal radiotherapy was completed less than 2 years before screening.
• Subjects with positive serum human chorionic gonadotropin (HCG) at screening; breastfeeding women.
• Subjects who have taken investigational medicinal products or participated in other clinical trials within 1 month prior to screening.
• Participants judged by the investigator to be unsuitable for enrollment in this clinical trial based on their medical history.