Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06317220
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-03-05
Brief Title:
Vedolizumab for the Treatment of Collagenous Gastritis
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Vedolizumab for the Treatment of Collagenous Gastritis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
The goal of this clinical trial is to learn about how vedolizumab may affect patients with collagenous gastritis CG The main questions it aims to answer are
Whether vedolizumab can reduce CG symptoms
Whether vedolizumab is safe to take for patients with CG
Participants in this study will
Receive vedolizumab through an IV infusion
Complete a survey at each infusion visit
Have blood collected at each infusion visit
Undergo an endoscopy with biopsy
Whether vedolizumab can reduce CG symptoms
Whether vedolizumab is safe to take for patients with CG
Participants in this study will
Receive vedolizumab through an IV infusion
Complete a survey at each infusion visit
Have blood collected at each infusion visit
Undergo an endoscopy with biopsy
Detailed Description:
Eligible participants will receive vedolizumab through an IV in their arm infusion at week 0 then week 2 then week 6 Participants who respond well to the treatment after the first 3 infusions and are interested in continuing will receive vedolizumab every 8 weeks for about 1 year At each visit participants will be asked about their collagenous gastritis symptoms and any changes in their health
Blood samples will be collected from participants at every vedolizumab infusion Some of these samples will be collected for safety purposes some will be collected to monitor CG progression and some will be collected for research purposes
A few months after beginning treatment the study doctor will perform an upper endoscopy to help determine whether vedolizumab has improved each participants CG An upper endoscopy is a procedure where the doctor inserts a small tube with a camera through the mouth and down the throat to look at the upper gastrointestinal tract the esophagus stomach and part of the small intestine During the procedure biopsies will be collected to monitor CG and for research purposes All participants will be given medication to make them comfortable throughout the duration of the procedure which lasts approximately 10 to 30 minutes
Blood samples will be collected from participants at every vedolizumab infusion Some of these samples will be collected for safety purposes some will be collected to monitor CG progression and some will be collected for research purposes
A few months after beginning treatment the study doctor will perform an upper endoscopy to help determine whether vedolizumab has improved each participants CG An upper endoscopy is a procedure where the doctor inserts a small tube with a camera through the mouth and down the throat to look at the upper gastrointestinal tract the esophagus stomach and part of the small intestine During the procedure biopsies will be collected to monitor CG and for research purposes All participants will be given medication to make them comfortable throughout the duration of the procedure which lasts approximately 10 to 30 minutes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None