Trial · Interventional
Active, not recruitingPhase 3Registry dataEfficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition
Overview
- Status
- Active, not recruiting
- Phase
- Phase 3
- Enrollment
- 72 participants (estimated)
- Sponsor
- Chongqing Peg-Bio Biopharm Co., Ltd. · Industry
- Design
- Randomized · Triple masking
- Countries
1 country
China
- Start
- 3 Sept 2024
- Primary completion
- 28 Sept 2026
- Completion
- 15 Mar 2027 (estimated)
- First posted
- 22 Jul 2024
- Last update posted
- 22 Oct 2026
- Conditions
- Short Bowel Syndrome
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 3
Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition
NCT065125843 Sept 2024 to est. 15 Mar 2027
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- PJ009Drug
- PJ009 PlaceboDrug
Arms2
Experimental
PJ009
subcutaneous injections, 0.05 mg/kg once daily
Placebo comparator
PJ009 Placebo
subcutaneous injections, once daily
Primary outcomes1
Outcomes the sponsor listed as primary.
Percentage of responders
Time frame · Week 20 to 24 of treatment period
Registry description
A responder's PN/IV volume per week shows a reduction of at least 20% from baseline from week 20 to 24 in treatment period.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 14 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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