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New treatment option for Short Bowel Syndrome (SBS) in Adults
Official title Phase IV Study of rhGH Injection in Adult Short Bowel Syndrome
ClinicalTrials.gov ID: NCT07691125
What this study is testing
What is rhGH injection?
rhGH injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for short bowel syndrome (sbs) in adults.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- All female participants who are not postmenopausal (last menstrual period ≥ 12 months prior to the screening visit) and have not undergone...
- Male participants must use contraception, or their female partners shall satisfy any of the conditions specified in Item 5 above;
You likely can't join if
- people with a history of allergic reactions to the study drug or its analogues; people unsuitable for subcutaneous injection, including those...
- people with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and HBV DNA ≥ 1000 IU/mL within 6 months prior to...
- people with a prior diagnosis of malignant tumors before screening.
- people with consciousness disturbance, a history of psychiatric illness, or severe neurological dysfunction.
- people with glycated hemoglobin (HbA1c) ≥ 7% at screening.
- people with any of the following clinically significant cardiovascular disorders:
See the full eligibility 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...
- 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.
- people with a history of allergic reactions to the study drug or its analogues; people unsuitable for subcutaneous injection, including those receiving anticoagulant therapy, presenting with thrombocytopenia, known...
- people 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; people with positive anti-HCV antibody and HCV RNA level...
- people with a prior diagnosis of malignant tumors before screening.
- people with consciousness disturbance, a history of psychiatric illness, or severe neurological dysfunction.
- people with glycated hemoglobin (HbA1c) ≥ 7% at screening.
- people 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;
- people 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 people or ≥ 480 ms for female people at screening (calculated via the Fridericia correction formula: QTc = QT/RR⁰ ³³), or a medical history of prolonged QTc interval.
- people 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.
- people 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...
- people who have received stem cell therapy, any form of bone marrow transplantation, or solid organ transplantation.
- people whose abdominal radiotherapy was completed less than 2 years before screening.
- people with positive serum human chorionic gonadotropin (HCG) at screening; breastfeeding women.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Xiamen, Fujian, China
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xiamen, Fujian, China; Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.