Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004368
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Phase I Study of Colchicine Therapy in Childhood Hepatic Cirrhosis
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2003-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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 Investigate the efficacy and safety of colchicine therapy in improving hepatic function and reducing hepatic fibrosis scarring in children with hepatic cirrhosis
I Investigate the efficacy and safety of colchicine therapy in improving hepatic function and reducing hepatic fibrosis scarring in children with hepatic cirrhosis
Detailed Description:
PROTOCOL OUTLINE Patients receive colchicine orally twice daily for 24 months After the first month the dose of colchicine will increase and remain at that dose for the duration of study
Patients are evaluated every 6 months during study
Patients are evaluated every 6 months during study
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 |
|---|---|---|---|
| CHD-1089 | None | None | None |