Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443502
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-30
Brief Title:
A Study to Learn About the Safety of Vedolizumab and How Well it Works in Children and Teenagers With Active Chronic Pouchitis
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
An Open-label Single-Arm Phase 3 Study to Evaluate the Efficacy Safety Tolerability Pharmacokinetics and Immunogenicity of Vedolizumab Intravenous in the Treatment of Pediatric Subjects With Active Chronic Pouchitis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
When some people have their large bowel removed a surgeon can make a pouch from part of the small bowel to connect it to the back passage anus Pouchitis is when the pouch becomes inflamed swollen or infected The main aim of this study is to find out if vedolizumab improves pouchitis symptoms and pouch inflammation Other aims include to find out if vedolizumab is well tolerated and if it causes any medical problems adverse events or side effects and to look for any changes in the well-being of participants during their treatment with vedolizumab
Participants will receive up to 6 infusions of vedolizumab First 3 infusions are in first 6 weeks Day 1 Week 2 and Week 6 Participants who are getting benefit may continue with the treatment for up to 75 months 30 weeks in total After completing treatment with vedolizumab participants will visit their clinic for a health check at Week 34 One final health check will be scheduled 45 months 18 weeks after the last vedolizumab infusion
Participants who continue to benefit from their treatment at the end of this study will be invited to continue treatment with vedolizumab in another clinical study Vedolizumab-3042
Participants will receive up to 6 infusions of vedolizumab First 3 infusions are in first 6 weeks Day 1 Week 2 and Week 6 Participants who are getting benefit may continue with the treatment for up to 75 months 30 weeks in total After completing treatment with vedolizumab participants will visit their clinic for a health check at Week 34 One final health check will be scheduled 45 months 18 weeks after the last vedolizumab infusion
Participants who continue to benefit from their treatment at the end of this study will be invited to continue treatment with vedolizumab in another clinical study Vedolizumab-3042
Detailed Description:
The drug being tested in this study is called vedolizumab This study will look at the efficacy safety tolerability pharmacokinetics PK and immunogenicity of vedolizumab in pediatric participants with active chronic pouchitis
The study will enroll approximately 30 participants All the participants will be enrolled in a single treatment group to receive treatment with vedolizumab along with ciprofloxacin metronidazole or other antibiotics based on participants weight mentioned as follows
Participants with body weight greater than or equal to 30 kilogram kg will receive vedolizumab high dose
Participants with body weight greater than 15 to less than 30 kg will receive vedolizumab medium dose
Participants with body weight 10 to 15 kg will receive vedolizumab low dose
All participants will receive vedolizumab intravenous infusion at Day 1 Weeks 2 6 14 22 and 30 along with concomitant antibiotic treatment from Day 1 through Week 2
This multi-center trial will be conducted globally The overall duration of the study is up to 57 weeks Participants will be followed up for 18 weeks after the last dose of the study drug for safety
The study will enroll approximately 30 participants All the participants will be enrolled in a single treatment group to receive treatment with vedolizumab along with ciprofloxacin metronidazole or other antibiotics based on participants weight mentioned as follows
Participants with body weight greater than or equal to 30 kilogram kg will receive vedolizumab high dose
Participants with body weight greater than 15 to less than 30 kg will receive vedolizumab medium dose
Participants with body weight 10 to 15 kg will receive vedolizumab low dose
All participants will receive vedolizumab intravenous infusion at Day 1 Weeks 2 6 14 22 and 30 along with concomitant antibiotic treatment from Day 1 through Week 2
This multi-center trial will be conducted globally The overall duration of the study is up to 57 weeks Participants will be followed up for 18 weeks after the last dose of the study drug for safety
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-504773-20 | OTHER | EU CT Number | None |