A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of PJ009 in Patients with Short Bowel Syndrome Requiring Parenteral Nutrition
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.
• Male and female aged ≥ 14 years;
• SBS patients dependent on PN/IV support for at least 6 consecutive months due to major intestinal resection;
• At least 3 PN/IV support sessions per week are required 1 week before screening or 2 weeks before baseline;
• Be on stable PN/IV support for at least 4 consecutive weeks before administration;
• For subjects with a history of Crohn's disease (CD), clinical assessment of remission for at least 12 weeks prior to administration;
• Be able to understand and provide signed informed consent, for those under 18 years old, the guardian should also sign the informed consent;
• Be able to complete experiments in accordance with the protocol.