Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT04872920
Status:
UNKNOWN
Last Update Posted:
2022-08-30
First Post:
2021-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Registry on Patients With Endogenous CS to Document Safety and Effectiveness of Ketoconazole.
Sponsor:
HRA Pharma
Organization:
Study Overview
Official Title:
Prospective, Multi-country, Observational Registry to Collect Clinical Information on Patients With Endogenous Cushing's Syndrome to Assess Drug Utilization Pattern and to Document the Safety and Effectiveness of Ketoconazole.
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
RECRUITING
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:
KetoPASS
Brief Summary:
This is a non-interventional, prospective, multinational, multicentre, observational study, in which data collected are those derived from routine clinical practice via an European registry on CS: ERCUSYN.
Detailed Description:
The aim is to further document the safety and efficacy of Ketoconazole HRA administered in routine clinical practice in patients with CS.
The study operates under real clinical practice conditions, i.e. there is no treatment protocol thus.
The study operates under real clinical practice conditions, i.e. there is no treatment protocol thus.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?: