Clinical Research Directory
Browse clinical research sites, groups, and studies.
Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition
Sponsor: Chongqing Peg-Bio Biopharm Co., Ltd.
Summary
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.
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of PJ009 in Patients With Short Bowel Syndrome Requiring Parenteral Nutrition
Key Details
Gender
All
Age Range
14 Years - Any
Study Type
INTERVENTIONAL
Enrollment
72
Start Date
2024-09-03
Completion Date
2026-04-27
Last Updated
2026-03-02
Healthy Volunteers
No
Conditions
Interventions
PJ009
subcutaneous injections, 0.05 mg/kg once daily
PJ009 Placebo
subcutaneous injections, once daily
Locations (8)
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Chongqing General Hospital
Chongqing, Chongqing Municipality, China
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
The Third Xiangya Hospital of Central South University
Changsha, Hu'Nan, China
General Hospital of Eastern Theater Command
Nanjing, Jiangsu, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China