Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00319046
Status:
COMPLETED
Last Update Posted:
2018-11-21
First Post:
2006-04-26
Brief Title:
Clinical Study to Evaluate the Long Term Efficacy Safety and Tolerability of Miglustat in Patients With Stable Type 1 Gaucher Disease
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
Open-label Non Comparative Multi-center Study to Evaluate the Long Term Efficacy Safety and Tolerability of Oral Miglustat as a Maintenance Therapy After a Switch From Enzyme Replacement Therapy in Adult Patients With Stable Type 1 Gaucher Disease
Status:
COMPLETED
Status Verified Date:
2018-10
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:
Although miglustat has been approved as a treatment for mild to moderate type 1 Gaucher disease in patients who are unsuitable for enzyme replacement therapy ERT more data are required to establish the long term efficacy safety and tolerability of miglustat in maintaining diseases stability after a switch from ERT
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None