Ignite Creation Date:
2024-05-05 @ 9:58 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00992459
Status:
COMPLETED
Last Update Posted:
2024-07-09
First Post:
2009-10-08
Brief Title:
Efficacy and Safety of HPN-100 for the Treatment of Adults With Urea Cycle Disorders
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Phase 3 Randomized Double-Blind Cross-Over Active-Controlled Study of the Efficacy and Safety of HPN-100 Glyceryl Tri-4-phenylbutyrate for the Treatment of Adults With Urea Cycle Disorders Help UCD
Status:
COMPLETED
Status Verified Date:
2024-06
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:
This was a randomized active-controlled double-blind cross-over study designed to enroll subjects with UCDs who are being treated with NaPBA
Detailed Description:
This was a randomized active-controlled double-blind cross-over study designed to enroll subjects with UCDs who are being treated with NaPBA Subjects were randomly assigned to receive either HPN-100 NaPBA placebo or NaPBA HPN 100 placebo for 2 weeks and then crossed over to receive the other treatment for 2 weeks Venous ammonia was the primary outcome measure Subjects were admitted to the clinical research unit for 24 hours of pharmacokinetic PK blood and urine sampling including an overnight stay at the end of each treatment period by which time the study drug had reached steady state
Subjects followed a stable diet throughout the study as prescribed by the investigator and dietician Throughout the study diet diaries were completed by the subject and dietary protein intake were assessed by a dietician based on completed dietary diaries and consultation with the subject
Subjects who completed this study and met the study entry criteria were offered the opportunity to enroll in the HPN-100 open-label safety protocol HPN-100-007
Study acquired from Horizon in 2024
Subjects followed a stable diet throughout the study as prescribed by the investigator and dietician Throughout the study diet diaries were completed by the subject and dietary protein intake were assessed by a dietician based on completed dietary diaries and consultation with the subject
Subjects who completed this study and met the study entry criteria were offered the opportunity to enroll in the HPN-100 open-label safety protocol HPN-100-007
Study acquired from Horizon in 2024
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