Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06591468
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-07
Brief Title:
A Multicenter Randomized Controlled Trial of Prednisone Combined with Ursodeoxycholic Acid in the Treatment of Primary Biliary Cholangitis with Moderate to Severe Interface Hepatitis Characteristics
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Randomized Controlled Trial of Prednisone Combined with Ursodeoxycholic Acid in the Treatment of Primary Biliary Cholangitis with Moderate to Severe Interface Hepatitis Characteristics
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
About 13 of patients with primary biliary cholangitis PBC exhibit moderate to severe interface hepatitis and this group of patients have poor response to UDCA treatment However as it is not yet sufficient to diagnose autoimmune hepatitis or overlap syndrome it is difficult to initiate immunosuppressive therapy such as steroids according to current guidelines The aim of this study is to explore whether PBC patients with moderate to severe interfacial inflammation can benefit from UDCA combined with prednisone therapy and its treatment safety
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None