ClinicalTrials.gg
RecruitingNCT07691125Updated Jul 8, 2026

Phase IV Study of rhGH Injection in Adult Short Bowel Syndrome

A Phase 4 interventional study of rhGH injection in Short Bowel Syndrome (SBS) in Adults, sponsored by Changchun GeneScience Pharmaceutical Co., Ltd.. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.

Sponsored by Changchun GeneScience Pharmaceutical Co., Ltd. · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Jul 2024, registered Jul 2026).
  • Started Jul 2024; still recruiting 2 years 3 months later.

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Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 12 studies in Short Bowel Syndrome with a site in China — 4 open to participants now, 6 under way, 2 of them phase 3. Short Bowel Syndrome · China.

Planned enrollment
2nd of 10
100 · median 27
Started
2024
with 1 other
Phase 4
2 of 12
1 open now
Registered
11th of 12
by date
Lead sponsor
1 of 12
Changchun GeneScience Pharmaceutical Co., Ltd.

Among the 12 studies in Short Bowel Syndrome with a site in China, this one is the 2nd largest by planned enrollment of the 10 interventional ones that give a count, is one of 2 that started in 2024, is one of 2 in phase 4, and was the 11th registered.

Short Bowel Syndrome

159 studies on the registry are indexed under Short Bowel Syndrome; 24 are open to participants now.

Browse Short Bowel Syndrome studies →

Open to participants now

4 of the 12 studies in Short Bowel Syndrome with a site in China are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 18 Short Bowel Syndrome studies recruiting now, 8 (44%) set no upper age limit and 8 (44%) stop at 75 or younger; 9 take children under 18; 2 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 12 studies in Short Bowel Syndrome with a site in China, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Short Bowel Syndrome (SBS) in Adults

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Aged 18 years or older, regardless of gender;
  2. Diagnosed with Short Bowel Syndrome (SBS);
  3. Total ≤ 1.5 times the (ULN); (ALT) and aspartate transaminase (AST) ≤ 3 times the ULN; serum creatinine for renal function ≤ 1.5 times the ULN;
  4. All female participants who are not (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 method from the date of signing the form until 1 month after the last Saizeng® treatment;
  5. Male participants must use contraception, or their female partners shall satisfy any of the conditions specified in Item 5 above;
  6. Able to voluntarily sign the informed consent form and willing to complete the trial in full compliance with the study protocol.

Exclusion criteria

Exclusion Criteria:

  1. 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).
  2. Subjects with positive 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- antibody and HCV RNA level exceeding the (ULN) set by the study center.
  3. Subjects with a prior diagnosis of malignant tumors before screening.
  4. Subjects with consciousness disturbance, a history of psychiatric illness, or severe neurological dysfunction.
  5. Subjects with (HbA1c) ≥ 7% at screening.
  6. Subjects with any of the following cardiovascular disorders:

    • History of chronic congestive heart failure with (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;
    • ≥ 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.
  7. 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.
  8. Subjects suffering from diseases requiring daily systemic therapy (prednisone ≥ 10 mg/day or equivalent doses of other glucocorticoids) or therapy (e.g., active inflammatory bowel disease, 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.
  9. Subjects who have received stem cell therapy, any form of bone marrow transplantation, or solid organ transplantation.
  10. Subjects whose abdominal radiotherapy was completed less than 2 years before screening.
  11. Subjects with positive serum human chorionic gonadotropin (HCG) at screening; breastfeeding women.
  12. Subjects who have taken medicinal products or participated in other clinical trials within 1 month prior to screening.
  13. Participants judged by the investigator to be unsuitable for enrollment in this clinical trial based on their medical history.
Terms in these criteria, in plain language(16)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    rhGH injection

    Biological: rhGH injection

Interventions

06

What researchers measure

Primary outcomes

  1. Change from baseline in total volume of parenteral nutrition (PN/IV) support at Week 4 of the study (PS, Parenteral Support)

    Time frame: 4 weeks

07

Study locations

2 of 2 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2024 (actual). Primary completion is estimated for Apr 2027, 32 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 1, 2026
First posted
Jul 8, 2026
StartActual
Jul 31, 2024
Primary completionEst.
Apr 28, 2027
CompletionEst.
Jun 10, 2028
Last update
Jul 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07691125
Responsible party
Sponsor
First posted
Jul 8, 2026
Start date
Jul 31, 2024
Primary completion
Apr 28, 2027 (estimated)
Completion
Jun 10, 2028 (estimated)
Last update
Jul 8, 2026

Study contacts

Feifei Liu
Contact
liufeifei@genscigroup.com
+86 13156199093

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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