Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004443
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Study of NTBC for Tyrosinemia I
Sponsor:
University of Washington
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-04
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 Assess the safety and efficacy of NTBC in children with tyrosinemia I
II Evaluate the effects of NTBC on survival rate of neurologic crises improvement in renal tubular damage reduction in the need for liver transplantation and reduction in the development of hepatocarcinoma in these patients
II Evaluate the effects of NTBC on survival rate of neurologic crises improvement in renal tubular damage reduction in the need for liver transplantation and reduction in the development of hepatocarcinoma in these patients
Detailed Description:
PROTOCOL OUTLINE Patients are stratified according to age at onset of symptoms 0-2 months vs 2-6 months vs greater than 6 months
Patients receive oral NTBC twice a day Treatment continues in the absence of unacceptable toxicity
Patients are followed once a month for 6 months then every 3 months thereafter
Completion date provided represents the completion date of the grant per OOPD records
Patients receive oral NTBC twice a day Treatment continues in the absence of unacceptable toxicity
Patients are followed once a month for 6 months then every 3 months thereafter
Completion date provided represents the completion date of the grant per OOPD records
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 |
|---|---|---|---|
| UWASH-FDR001445 | None | None | None |