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

Recruiting Phase 3 Interventional Study
Short Bowel Syndrome
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
14 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
72 (estimated)
Sponsor
Chongqing Peg-Bio Biopharm Co., Ltd. · Industry
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About This Trial
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 se…
Trial Locations
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Eligibility Criteria
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/I…
Contacts

Jing Sun

86-13983367811

sunj@pegbiocq.com

CONTACT