Actively Recruiting
Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition
Led by Chongqing Peg-Bio Biopharm Co., Ltd. · Updated on 2026-03-02
72
Participants Needed
8
Research Sites
85 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main aim of this clinical trial is to assess the efficacy and safety of PJ009 in patients aged ≥14 with short bowel syndrome (SBS) requiring parenteral nutrition. The main questions it aims to answer are: * How effective is PJ009 in treating short bowel syndrome? * Is PJ009 safe in these patients? Researchers will compare PJ009 to a placebo (a look-alike substance that contains no drug) to see if PJ009 works to treat SBS. Participants will * Receive daily subcutaneous injections of PJ009 or placebo according to weight for 24 weeks, and then the participants receive placebo will be switched to receive PJ009 for another 12 weeks, while participants receive PJ009 continued the same treatment until the end of 36 weeks, * Visit the clinic at the end of week 1(w1), w2, w4, w8, w12, w16, w20, w24, w30 and w36 for assessment, * Keep a diary of the amount of their parenteral nutrition/ intravenous fluids (PN/IV), enteral nutrition and urine volume.
CONDITIONS
Official Title
Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female aged 14 years
- Patients with short bowel syndrome dependent on parenteral nutrition/intravenous support for at least 6 consecutive months due to major intestinal resection
- Require at least 3 parenteral nutrition/intravenous support sessions per week 1 week before screening or 2 weeks before baseline
- On stable parenteral nutrition/intravenous support for at least 4 consecutive weeks before treatment
- For those with Crohn's disease history, clinically assessed remission for at least 12 weeks before treatment
- Able to understand and provide signed informed consent; guardian consent required if under 18 years old
- Able to complete study procedures according to protocol
You will not qualify if you...
- Previous use of teduglutide or allergy to teduglutide or its components
- Use of natural GLP-2 or its analogs, human growth hormone or its analogs within 6 months before screening
- Use of glutamine, octreotide, GLP-1 analogs or dipeptidyl peptidase-IV inhibitors within 30 days before screening
- Active Crohn's disease or biological therapy changes within 6 months before screening
- Active inflammatory bowel disease or immunosuppressant therapy changes within 3 months before screening
- Unstable absorption due to cystic fibrosis, untreated megacolon, or known DNA abnormalities
- Clinically obvious intestinal obstruction or active stenosis within 6 months before screening
- Major gastrointestinal surgery within 3 months before screening (excluding esophageal intubation or endoscopic surgery)
- Severe, uncontrolled systemic diseases such as cardiovascular, respiratory, renal, infectious, endocrine, liver, or central nervous system diseases
- Malignant tumors within 5 years before screening, except certain treated cancers
- Severe liver function impairment as defined by specific bilirubin and transaminase levels
- Renal function impairment as defined by serum creatinine and creatinine clearance
- Pancreatic abnormalities as defined by serum amylase and lipase levels
- More than 4 SBS or parenteral nutrition-related hospitalizations within 12 months before screening
- Unplanned hospitalization within 30 days before screening
- Pregnant or lactating women, or those planning fertility or not using effective contraception during the trial
- Participation in any clinical trial (excluding antibody treatment trials) within 30 days before screening or antibody treatment trials within 3 months before screening
- Any other condition deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China, 102218
Not Yet Recruiting
2
Chongqing General Hospital
Chongqing, Chongqing Municipality, China, 401147
Not Yet Recruiting
3
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
Not Yet Recruiting
4
The Third Xiangya Hospital of Central South University
Changsha, Hu'Nan, China, 410013
Not Yet Recruiting
5
General Hospital of Eastern Theater Command
Nanjing, Jiangsu, China, 210016
Actively Recruiting
6
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266000
Not Yet Recruiting
7
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China, 200072
Not Yet Recruiting
8
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China, 710061
Not Yet Recruiting
Research Team
J
Jing Sun
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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