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Monoclonal Antibodies
Vedolizumab 300mg for Gastritis
Phase 2
Waitlist Available
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks (+/- 4 weeks)
Awards & highlights
Study Summary
"This trial aims to see if vedolizumab can help patients with collagenous gastritis by reducing symptoms and being safe to use. Participants will receive the drug through an IV, complete surveys,
Who is the study for?
This trial is for individuals with collagenous gastritis, a stomach condition causing inflammation and discomfort. Participants will receive vedolizumab infusions, complete surveys, provide blood samples, and undergo endoscopy with biopsy to monitor effects.Check my eligibility
What is being tested?
The study tests whether vedolizumab can alleviate symptoms of collagenous gastritis and assesses its safety. Vedolizumab is administered intravenously during the trial period while participants' health responses are closely monitored.See study design
What are the potential side effects?
Potential side effects of vedolizumab may include allergic reactions at the infusion site, headache, nausea, fever, fatigue or infections due to immune system suppression.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks (+/- 4 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks (+/- 4 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in symtpoms
Secondary outcome measures
Histologic response
Incidence of treatment-emergent adverse events (safety)
Response durability
Other outcome measures
Immunologic response in gastric mucosa
Immunologic response in peripheral blood
Side effects data
From 2019 Phase 4 trial • 11 Patients • NCT025597139%
Crohn's disease
9%
Gastrointestinal motility disorder
9%
Paronychia
9%
Viral infection
9%
Colitis ulcerative
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vedolizumab 300 mg
Trial Design
1Treatment groups
Experimental Treatment
Group I: Vedolizumab 300mgExperimental Treatment1 Intervention
Dose: 300mg
Administration: Intravenous (IV)
Frequency: Weeks 0, 2, 6, and then every 8 weeks
Duration: 54 weeks (1 year)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vedolizumab
2009
Completed Phase 4
~10330
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteOTHER
1,079 Previous Clinical Trials
340,967 Total Patients Enrolled
TakedaIndustry Sponsor
1,205 Previous Clinical Trials
4,187,959 Total Patients Enrolled
2 Trials studying Gastritis
1,680 Patients Enrolled for Gastritis
Massachusetts General HospitalLead Sponsor
2,936 Previous Clinical Trials
13,198,711 Total Patients Enrolled
1 Trials studying Gastritis
162 Patients Enrolled for Gastritis
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients currently able to participate in this ongoing research study?
"As per clinicaltrials.gov, the current status of this research trial does not involve participant recruitment. The study was first listed on May 1st, 2024, and last modified on March 11th, 2024. While this specific trial is not accepting new participants currently, it's noteworthy that there are ongoing enrollment opportunities in a total of 21 other trials."
Answered by AI
What is the potential harm of administering Vedolizumab at a dosage of 300mg to individuals?
"Based on our assessment at Power, the safety rating for Vedolizumab 300mg is a 2. This score reflects the available safety data in this Phase 2 trial without evidence yet supporting efficacy."
Answered by AI
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