Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05835505
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2023-04-18
Brief Title:
Detoxification of the Liver In PSC Dolphin
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Detoxification of the Liver in Primary Sclerosing Cholangitis
Status:
RECRUITING
Status Verified Date:
2023-12
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:
DOLPHIN
Brief Summary:
This study is a clinical trial being done to investigate the efficacy of drug BRS201 as a treatment in patients with primary sclerosing cholangitis Participation in this study will take 8 weeks long and the study is structured as a cross-over study in which participants will take the study drug for 4 weeks and a placebo drug for 4 weeks in a randomized order in the form of an oral medication Participation may also involve receiving an IV dose of the medication The study will require participants to attend 9 study visits all of which will be remote Participation will involve taking an oral medication twice daily tracking the medication in a log and getting blood drawn and giving a stool sample for a few lab tests throughout the study For the lab tests a research nurse will visit the participant in-home for the convenience of the participant
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None