Efficacy and Safety of PJ009 in Patients with Short Bowel Syndrome Requiring Parenteral Nutrition

Launched by CHONGQING PEG-BIO BIOPHARM CO., LTD. · Jul 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called PJ009 for patients aged 14 and older who have Short Bowel Syndrome (SBS) and rely on parenteral nutrition (PN), which is nutrition given through an IV. The main goal is to see if PJ009 is effective in improving their condition and whether it is safe to use. Participants will receive either PJ009 or a placebo (a substance with no active medicine) through daily injections for 24 weeks. After that, those who started with the placebo will switch to PJ009 for another 12 weeks. Throughout the trial, participants will visit the clinic regularly for check-ups and will keep a diary to track their nutrition and fluid intake.

To be eligible for the trial, participants must be at least 14 years old, have been dependent on parenteral nutrition for at least six months due to significant intestinal surgery, and have stable nutrition support for at least four weeks before starting. Some medical conditions and previous treatments may exclude certain individuals from participating. This trial is currently recruiting, and it's a chance for eligible patients to receive potentially new treatment while contributing to medical research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male and female aged ≥ 14 years;
• • 2. SBS patients dependent on PN/IV support for at least 6 consecutive months due to major intestinal resection;
• • 3. At least 3 PN/IV support sessions per week are required 1 week before screening or 2 weeks before baseline;
• • 4. Be on stable PN/IV support for at least 4 consecutive weeks before administration;
• • 5. For subjects with a history of Crohn's disease (CD), clinical assessment of remission for at least 12 weeks prior to administration;
• • 6. Be able to understand and provide signed informed consent, for those under 18 years old, the guardian should also sign the informed consent;
• • 7. Be able to complete experiments in accordance with the protocol.
• Exclusion Criteria:
• • 1. Have used teduglutide in the past or may be allergic to teduglutide or its components;
• • 2. Have used natural GLP-2 or its analogs, human growth hormone or its analogs within 6 months before screening;
• • 3. Have used glutamine, octreotide, GLP-1 analogs or dipeptidyl peptidase-IV inhibitors within 30 days before screening;
• • 4. With active Crohn's disease or those who need to change biological therapy within 6 months before screening;
• • 5. With active inflammatory bowel disease (IBD) or IBD patients who have received immunosuppressant therapy changes in the past 3 months;
• • 6. With unstable absorption due to cystic fibrosis, untreated megacolon disease or known DNA abnormalities (such as familial adenomatous polyposis, Fanconi syndrome);
• • 7. With clinically obvious intestinal obstruction or active stenosis within 6 months before screening;
• • 8. Have undergone major gastrointestinal surgical intervention within 3 months before screening, such as continuous transverse enteroplasty or other intestinal lengthening surgery (esophageal intubation or endoscopic surgery is allowed);
• • 9. Severe active, uncontrolled, untreated systemic diseases (such as cardiovascular, respiratory, renal, infectious, endocrine, liver or central nervous system diseases, etc.);
• • 10. Have malignant tumors within 5 years before screening (except for fully treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery);
• 11. With severe liver function impairment:
• • 1. Total bilirubin ≥ 2.0 × upper limit of normal (ULN); for patients with Gilbert's syndrome, direct bilirubin ≥ 2.0 × ULN;
• • 2. Aspartate transaminase (AST) ≥ 5.0 × ULN, alanine transaminase (ALT) ≥5.0 × ULN;
• 12. With renal function impairment:
• • 1. Serum creatinine ≥2.0 × ULN;
• • 2. Creatinine clearance \< 60 ml/min (calculated according to the Cockcroft-Gault formula, see Appendix 3 for details);
• 13. Pancreatic abnormalities:
• • 1. Serum amylase ≥ 2.0 × ULN;
• • 2. Serum lipase ≥ 2.0 × ULN;
• • 14. More than 4 SBS or PN-related hospitalizations (such as catheter sepsis, intestinal obstruction, severe water and electrolyte disorders) within 12 months before screening;
• • 15. Unplanned hospitalization within 30 days before screening;
• • 16. Pregnant or lactating women, women or men who have fertility plans or do not agree to take effective contraceptive measures during the trial;
• • 17. Participated in any clinical trial (excluding antibody treatment-related clinical trials) within 30 days before screening or participated in any antibody treatment-related clinical trials within 3 months before screening;
• • 18. Other condition the investigator believes would be unsuitable for participation in this clinical study.