Condition: Short Bowel Syndrome · Sponsor: Chongqing Peg-Bio Biopharm Co., Ltd.
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.
This description comes directly from the study's public registry record.
Jing Sun · 86-13983367811 · sunj@pegbiocq.com
Always discuss trial participation with your own doctor first.
| Beijing Tsinghua Changgung Hospital | Beijing, Beijing Municipality, China | Not Yet Recruiting |
| Chongqing General Hospital | Chongqing, Chongqing Municipality, China | Not Yet Recruiting |
| The Sixth Affiliated Hospital of Sun Yat-sen University | Guangzhou, Guangdong, China | Not Yet Recruiting |
| The Third Xiangya Hospital of Central South University | Changsha, Hu'Nan, China | Not Yet Recruiting |
| General Hospital of Eastern Theater Command | Nanjing, Jiangsu, China | Recruiting |
| The Affiliated Hospital of Qingdao University | Qingdao, Shandong, China | Not Yet Recruiting |
| Shanghai Tenth People's Hospital | Shanghai, Shanghai Municipality, China | Not Yet Recruiting |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi’an, Shanxi, China | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT06512584