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This is a multicenter, open-label, single-arm clinical trial. A total of 100 participants with short bowel syndrome (SBS) receiving parenteral nutrition (PN) support are planned to be enrolled. The trial includes a 2-week run-in phase and a 4-week intervention phase, during which participants will receive rhGH injections. A safety follow-up period will then be conducted through Week 52.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rhGH injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhGH injection | Biological | rhGH injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in total volume of parenteral nutrition (PN/IV) support at Week 4 of the study (PS, Parenteral Support) | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feifei Liu | Contact | +86 13156199093 | liufeifei@genscigroup.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Affiliated to Xiamen University | Recruiting | Xiamen | Fujian | 361004 | China | |
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| ID | Term |
|---|---|
| D012778 | Short Bowel Syndrome |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| General Hospital of Eastern Theater Command |
| Recruiting |
| Nanjing |
| Jiangsu |
| 210002 |
| China |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |