Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004338
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Study of Zinc for Wilson Disease
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2003-12
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 Establish the safety and efficacy of extended maintenance zinc therapy in 200 patients with Wilson disease
II Establish further the role of zinc in the prophylactic treatment of presymptomatic patients by increasing the current cohort from 80 to at least 100 patients
III Establish further the role of zinc therapy in pregnant patients with Wilson disease
IV Establish further the role of zinc therapy in children with Wilson disease
II Establish further the role of zinc in the prophylactic treatment of presymptomatic patients by increasing the current cohort from 80 to at least 100 patients
III Establish further the role of zinc therapy in pregnant patients with Wilson disease
IV Establish further the role of zinc therapy in children with Wilson disease
Detailed Description:
PROTOCOL OUTLINE
Patients receive copper regulation therapy with zinc acetate an existing cohort on maintenance therapy will be followed for long-term data collection presymptomatic patients are treated prophylactically and pregnant patients are evaluated for fetal outcome All patients are evaluated for copper balance clinical control and toxicity
Patients receive copper regulation therapy with zinc acetate an existing cohort on maintenance therapy will be followed for long-term data collection presymptomatic patients are treated prophylactically and pregnant patients are evaluated for fetal outcome All patients are evaluated for copper balance clinical control and toxicity
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-310 | None | None | None |