RecruitingPhase 3NCT06512584

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

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


Sponsor

Chongqing Peg-Bio Biopharm Co., Ltd.

Enrollment

72 participants

Start Date

Sep 3, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 14 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called PJ009 and a drug called PJ009 Placebo for people with short bowel syndrome. The study is currently recruiting participants at 8 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPJ009

subcutaneous injections, 0.05 mg/kg once daily

DRUGPJ009 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

View Full Details on ClinicalTrials.gov

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NCT06512584


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