Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-01-03 @ 8:43 PM
Study NCT ID:
NCT03035058
Status:
WITHDRAWN
Last Update Posted:
2017-03-08
First Post:
2017-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Vedolizumab Intravenous (IV) in the Treatment of Primary Sclerosing Cholangitis in Subjects With Underlying Inflammatory Bowel Disease
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
A Randomized, Global, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Vedolizumab IV for the Treatment of Primary Sclerosing Cholangitis, With Underlying Inflammatory Bowel Disease
Status:
WITHDRAWN
Status Verified Date:
2017-03
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 purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) in non-end-stage primary sclerosing cholangitis (PSC) participants with underlying inflammatory bowel disease (IBD).
Detailed Description:
The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have non-end-stage primary sclerosing cholangitis (PSC) with underlying inflammatory bowel disease (IBD). This study will look at changes in fibrosis staging in people who take vedolizumab.
The study will enroll approximately 258 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups in ratio 1:1:1-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
* Vedolizumab 300 mg once every 4 weeks (Q4W)
* Vedolizumab 300 mg once every 8 weeks (Q8W)
* Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient
All participants will be administered vedolizumab or placebo via intravenous infusion
This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 124 weeks. Participants will make multiple visits to the clinic and will be contacted by telephone 6 months after last dose of study drug for a follow-up assessment.
The study will enroll approximately 258 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups in ratio 1:1:1-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
* Vedolizumab 300 mg once every 4 weeks (Q4W)
* Vedolizumab 300 mg once every 8 weeks (Q8W)
* Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient
All participants will be administered vedolizumab or placebo via intravenous infusion
This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 124 weeks. Participants will make multiple visits to the clinic and will be contacted by telephone 6 months after last dose of study drug for a follow-up assessment.
Study Oversight
Has Oversight DMC:
True
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?: