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Tests treatment safety and results for Short Bowel Syndrome
Official title Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition
ClinicalTrials.gov ID: NCT06512584
What this study is testing
What is PJ009?
PJ009 is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for short bowel syndrome.
Also referred to as Glucagon-Like Peptide 2 (GLP-2) analogue.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 and older
You may be able to join if
- 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 people with a history of Crohn's disease (CD), clinical assessment of remission for at least 12 weeks prior to administration;
You likely can't join if
- Have used teduglutide in the past or may be allergic to teduglutide or its components;
- Have used natural GLP-2 or its analogs, human growth hormone or its analogs within 6 months before screening;
- Have used glutamine, octreotide, GLP-1 analogs or dipeptidyl peptidase-IV inhibitors within 30 days before screening;
- With active Crohn's disease or those who need to change biological therapy within 6 months before screening;
- With active inflammatory bowel disease (IBD) or IBD patients who have received immunosuppressant therapy changes in the past 3 months;
- With unstable absorption due to cystic fibrosis, untreated megacolon disease or known DNA abnormalities (such as familial adenomatous polyposis...
See the full eligibility criteria
- 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 people 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.
- Have used teduglutide in the past or may be allergic to teduglutide or its components;
- Have used natural GLP-2 or its analogs, human growth hormone or its analogs within 6 months before screening;
- Have used glutamine, octreotide, GLP-1 analogs or dipeptidyl peptidase-IV inhibitors within 30 days before screening;
- With active Crohn's disease or those who need to change biological therapy within 6 months before screening;
- With active inflammatory bowel disease (IBD) or IBD patients who have received immunosuppressant therapy changes in the past 3 months;
- With unstable absorption due to cystic fibrosis, untreated megacolon disease or known DNA abnormalities (such as familial adenomatous polyposis, Fanconi syndrome);
- With clinically obvious intestinal obstruction or active stenosis within 6 months before screening;
- 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...
- Severe active, uncontrolled, untreated systemic diseases (such as cardiovascular, respiratory, renal, infectious, endocrine, liver or central nervous system diseases, etc.);
- 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...
- With severe liver function impairment:
- Total bilirubin ≥ 2.0 × upper limit of normal (ULN); for patients with Gilbert's syndrome, direct bilirubin ≥ 2.0 × ULN;
- Aspartate transaminase (AST) ≥ 5.0 × ULN, alanine transaminase (ALT) ≥5.0 × ULN;
- With renal function impairment:
- Serum creatinine ≥2.0 × ULN;
- Creatinine clearance \< 60 ml/min (calculated according to the Cockcroft-Gault formula, see Appendix 3 for details);
- Pancreatic abnormalities:
- Serum amylase ≥ 2.0 × ULN;
- Serum lipase ≥ 2.0 × ULN;
- More than 4 SBS or PN-related hospitalizations (such as catheter sepsis, intestinal obstruction, severe water and electrolyte disorders) within 12 months before screening;
- Unplanned hospitalization within 30 days before screening;
- Pregnant or lactating women, women or men who have fertility plans or do not agree to take effective contraceptive measures during the trial;
- 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...
- Other condition the investigator believes would be unsuitable for participation in this clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Guangzhou, Guangdong, China
- Changsha, Hu'Nan, China
- Nanjing, Jiangsu, China
- Qingdao, Shandong, China
- Shanghai, Shanghai Municipality, China
- Xi’an, Shanxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Guangzhou, Guangdong, China; Changsha, Hu'Nan, China; Nanjing, Jiangsu, China; Qingdao, Shandong, China and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.