Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00104260
Status:
COMPLETED
Last Update Posted:
2007-04-09
First Post:
2005-02-24
Brief Title:
Study to Evaluate the Response to and Safety of an 8-Day Course of Phenoptin Treatment in Subjects With Phenylketonuria
Sponsor:
BioMarin Pharmaceutical
Organization:
BioMarin Pharmaceutical
Study Overview
Official Title:
A Phase 2 Multicenter Open-Label Study to Evaluate the Response to and Safety of an 8-Day Course of Phenoptin Treatment in Subjects With Phenylketonuria Who Have Elevated Phenylalanine Levels
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective is to evaluate the degree and frequency of response to Phenoptin sapropterin dihydrochloride as demonstrated by a reduction in blood phenylalanine Phe level among subjects with phenylketonuria PKU who have elevated Phe levels A secondary objective of this study is to evaluate the safety of Phenoptin treatment in this subject population and identify individuals in this subject population who respond to Phenoptin treatment with a reduction in blood Phe level
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