Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06512584
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Efficacy and Safety of PJ009 in Patients with Short Bowel Syndrome Requiring Parenteral Nutrition
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 1w1 w2 w4 w8 w12 w16 w20 w24 w30 and w36 for assessment
Keep a diary of the amount of their parenteral nutrition intravenous fluids PNIV enteral nutrition and urine volume
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 1w1 w2 w4 w8 w12 w16 w20 w24 w30 and w36 for assessment
Keep a diary of the amount of their parenteral nutrition intravenous fluids PNIV enteral nutrition and urine volume
Detailed Description:
This is a multicenter randomized double-blind placebo-controlled clinical study aiming to evaluate the efficacy safety immunogenicity and pharmacokinetic of PJ009 in patients with short bowel syndrome requiring parenteral nutrition using placebo as a control
The trial is divided into 3 periods Period 1 of this trial is the screening optimization if applicable up to 8 weeks and stabilization 4-8 weeks period At the end of the stabilization period a baseline enrollment evaluation will be performed and all eligible participants will enter the 24 weeks of double-blind treatment period period 2 Period 3 is a 12-week open label extension to period 2 Safety follow-up assessments will be performed 4 weeks after the last dose in treatment period 3
The trial is divided into 3 periods Period 1 of this trial is the screening optimization if applicable up to 8 weeks and stabilization 4-8 weeks period At the end of the stabilization period a baseline enrollment evaluation will be performed and all eligible participants will enter the 24 weeks of double-blind treatment period period 2 Period 3 is a 12-week open label extension to period 2 Safety follow-up assessments will be performed 4 weeks after the last dose in treatment period 3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None