Ignite Creation Date:
2024-05-06 @ 2:00 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01948427
Status:
TERMINATED
Last Update Posted:
2024-07-01
First Post:
2013-09-16
Brief Title:
Observational Study That Will Collect Information on Patients With Urea Cycle Disorders UCDs
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
Long-Term Registry of Patients With Urea Cycle Disorders UCDs
Status:
TERMINATED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
the study was terminated due to the primary end point being met
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THRIVE
Brief Summary:
THRIVE is an observational study that will collect information on patients with UCDs THRIVE will follow enrolled participants for up to 10 years As an observational study enrolled patients will not be required to make any additional office visits or take any medicine outside of normal care
Detailed Description:
UCDs disproportionately affect children and females depending on the severity of the defect a UCD can manifest shortly after birth or later in life This study will track long-term outcomes in UCD patients and effects of ammonia-scavenging agents on neuropsychological functions of UCD patients
This is a non-interventional multi-center registry to be conducted in patients with UCDs Investigators will prescribe treatments based on usual clinical practice and there will be no restrictions on the use of commercially available medications As an observational study this study will not change the patient healthcare provider relationship nor influence the healthcare providers drug prescription or the therapeutic management of the patient
Patients with UCDs will be recruited and invited to attend a Baseline visit After eligible patients are enrolled retrospective and baseline data will be collected Patients will be followed for up to 10 years during which time they will be assessed by their healthcare provider Patients and healthcare provider will be asked to report episodes of hyperammonemic crisis available ammonia values and other information
Study acquired from Horizon in 2024
This is a non-interventional multi-center registry to be conducted in patients with UCDs Investigators will prescribe treatments based on usual clinical practice and there will be no restrictions on the use of commercially available medications As an observational study this study will not change the patient healthcare provider relationship nor influence the healthcare providers drug prescription or the therapeutic management of the patient
Patients with UCDs will be recruited and invited to attend a Baseline visit After eligible patients are enrolled retrospective and baseline data will be collected Patients will be followed for up to 10 years during which time they will be assessed by their healthcare provider Patients and healthcare provider will be asked to report episodes of hyperammonemic crisis available ammonia values and other information
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