Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-01-13 @ 5:13 PM
Study NCT ID:
NCT00059202
Status:
TERMINATED
Last Update Posted:
2021-05-03
First Post:
2003-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of High-dose Urso in Primary Sclerosing Cholangitis
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Organization:
Study Overview
Official Title:
Multicentered Randomized Trial of High-dose Urso in Primary Sclerosing Cholangitis
Status:
TERMINATED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
DSMB reviewed interim analysis and terminated the study due to futility.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multicenter, randomized, controlled trial of high dose ursodiol versus placebo for patients with primary sclerosing cholangitis (PSC). The average duration of follow-up will be approximately five years with important clinical endpoints such as death, eligibility for liver transplantation, changes in histology and cholangiogram as well as liver biochemistries and quality of life data collected.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01DK056924 | NIH | None | https://reporter.nih.gov/quic… | View |