Ignite Creation Date:
2024-05-06 @ 12:33 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01609062
Status:
TERMINATED
Last Update Posted:
2016-02-01
First Post:
2012-05-24
Brief Title:
Safety and Exercise Study of Two Doses of BMN 110 for Morquio A Syndrome
Sponsor:
BioMarin Pharmaceutical
Organization:
BioMarin Pharmaceutical
Study Overview
Official Title:
A Randomized Double-Blind Pilot Study of the Safety and Physiological Effects of Two Doses of BMN 110 in Patients With Mucopolysaccharidosis IVA Morquio A Syndrome
Status:
TERMINATED
Status Verified Date:
2015-12
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:
The primary objective of this study was to evaluate the safety of a 20 mgkgweek and a 40 mgkgweek of BMN 110 in patients with Morquio A syndrome for up to 196 weeks Secondary objectives were to investigate the effect of the two doses on exercise capacity for up to 196 weeks In addition the pharmacokinetic PK parameters of both doses of BMN 110 was assessed
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