Short Bowel Syndrome (SBS) in AdultsPhase 4NCT07691125
Phase IV Study of rhGH Injection in Adult Short Bowel Syndrome
A Phase 4 study testing rhGH injection in people with Short Bowel Syndrome (SBS) in Adults, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Short Bowel Syndrome (SBS) in Adults
- What is being tested?
- rhGH injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 31 Jul 2024to 10 Jun 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older, regardless of gender;
- Diagnosed with Short Bowel Syndrome (SBS);
- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3 times the ULN; serum creatinine for renal function ≤ 1.5 times the ULN;
- All female participants who are not postmenopausal (last menstrual period ≥ 12 months prior to the screening visit) and have not undergone hysterectomy (or bilateral salpingectomy) must agree to use one recognized highly effective contraceptive method from the date of signing the informed consent form until 1 month after the last Saizeng® treatment;
- Male participants must use contraception, or their female partners shall satisfy any of the conditions specified in Item 5 above;
- Able to voluntarily sign the informed consent form and willing to complete the trial in full compliance with the study protocol.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
General Hospital of Eastern Theater Command
Nanjing, Jiangsu, 210002
- Recruiting
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, Fujian, 361004
About this study
Official title: Phase IV Clinical Study Evaluating Efficacy and Safety of Recombinant Human Growth Hormone Injection for Adult Short Bowel Syndrome
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.
- Conditions
- Short Bowel Syndrome (SBS) in Adults
- Being tested
- rhGH injection
- Medical subject headings
- Short Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhGH injectionBiological
rhGH injection
| Study group | Role | What they receive |
|---|---|---|
| rhGH injection | Experimental | Not described Receives: Biological: rhGH injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in total volume of parenteral nutrition (PN/IV) support at Week 4 of the study (PS, Parenteral Support)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start31 Jul 2024
- Primary completion28 Apr 2027 (estimated)
- Study completion10 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Bowel Syndrome (SBS) in AdultsStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691125
- Sponsor's protocol ID
- GenSci001-401
- Status last verified
- Jun 2026
- First submitted
- 1 Jul 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No