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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 2, 2026 (before its estimated March 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Site details revised at 8 of 8 sitesv4
  2. Start date changed from estimate of Sep 16, 2024 to Sep 3, 2024
    • Site contacts updated at 8 of 8 sites
    v3
  3. Start date: Jul 26, 2024 to Sep 16, 2024v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06512584
Lead Sponsor Chongqing Peg-Bio Biopharm Co., Ltd.
Conditions
(from sponsor)		 Short Bowel Syndrome
Related terms Short Bowel Syndrome
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov