Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004784
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase III Randomized Study of Ursodiol With Vs Without Methotrexate for Primary Biliary Cirrhosis
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-12
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:
None
Brief Summary:
OBJECTIVES I Compare the effects of ursodiol ursodeoxycholic acid with and without methotrexate on pruritus incapacitation index and serum markers of activity and severity in patients with primary biliary cirrhosis
II Compare the effects of these regimens on the development of ascites encephalopathy varices or bleeding from pre-existing varices histologic liver changes transplantation and survival
III Compare the toxicity and safety of each regimen
II Compare the effects of these regimens on the development of ascites encephalopathy varices or bleeding from pre-existing varices histologic liver changes transplantation and survival
III Compare the toxicity and safety of each regimen
Detailed Description:
PROTOCOL OUTLINE This is a randomized double-blind study Patients are stratified by participating institution and Ludwig histologic stage
All patients are treated with ursodiol ursodeoxycholic acid UDCA for 6 months If entry criteria continue to be met patients are randomly assigned to UDCAmethotrexate or UDCAplacebo
Combination therapy continues for at least 5 years
All patients are treated with ursodiol ursodeoxycholic acid UDCA for 6 months If entry criteria continue to be met patients are randomly assigned to UDCAmethotrexate or UDCAplacebo
Combination therapy continues for at least 5 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UTSMC-29205400 | None | None | None |