Ignite Creation Date:
2024-05-06 @ 10:43 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03335488
Status:
COMPLETED
Last Update Posted:
2024-07-01
First Post:
2017-10-18
Brief Title:
Study of Glycerol Phenylbutyrate Sodium Phenylbutyrate in Phenylbutyrate Naïve Patients With Urea Cycle Disorders UCDs
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Randomised Controlled Open-Label Parallel Arm Study of Safety PK and Ammonia Control of RAVICTI Glycerol Phenylbutyrate Oral Liquid and Sodium Phenylbutyrate in Phenylbutyrate Treatment Naïve Patients With Urea Cycle Disorders
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 is a randomized controlled open-label parallel arm study to assess the safety tolerability pharmacokinetics and ammonia control of RAVICTI as compared to Sodium phenylbutyrate NaPBA in urea cycle disorder subjects not currently or previously chronically treated with phenylacetic acid phenylacetate PAA prodrugs The study design will include 1 Baseline Period 2 Initial Treatment Period 3 a RAVICTI only Transition Period 4 a RAVICTI only Maintenance Period and 5 a RAVICTI only Safety Extension Period The study will run for approximately 25 weeks
Detailed Description:
Study acquired from Horizon in 2024
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-000075-27 | EUDRACT_NUMBER | None | None |