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Trial · Interventional

Active, not recruitingPhase 3Registry data

Efficacy 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
20242025202620272028
  1. Ph 3

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

    NCT06512584

    3 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.

  1. 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
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.

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