Phase IV Study of rhGH Injection in Adult Short Bowel Syndrome (NCT07691125) | Clinical Trial Compass
RecruitingPhase 4
Phase IV Study of rhGH Injection in Adult Short Bowel Syndrome
China100 participantsStarted 2024-07-31
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in total volume of parenteral nutrition (PN/IV) support at Week 4 of the study (PS, Parenteral Support)
. 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.