Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004333
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Phase II Study of the Enzyme Inhibitor NTBC for Tyrosinemia Type I
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-07
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
Assess whether 2-2-nitro-4-trifluoromethylbenzoyl-13-cyclohexanedione NTBC at 06 mgkg per day prevents liver failure in at least 1 patient with tyrosinemia type I
Assess whether 2-2-nitro-4-trifluoromethylbenzoyl-13-cyclohexanedione NTBC at 06 mgkg per day prevents liver failure in at least 1 patient with tyrosinemia type I
Detailed Description:
PROTOCOL OUTLINE Only 2 patients with tyrosinemia type I are known to this research team others will be treated if found and if clinical conditions permit
The enzyme inhibitor 2-2-nitro-4-trifluoromethylbenzoyl-13-cyclohexanedione NTBC is administered orally in 2 divided doses daily with meals
Patients will be followed closely for side effects attributable to NTBC
The enzyme inhibitor 2-2-nitro-4-trifluoromethylbenzoyl-13-cyclohexanedione NTBC is administered orally in 2 divided doses daily with meals
Patients will be followed closely for side effects attributable to NTBC
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 |
|---|---|---|---|
| UMMC-1319 | None | None | None |