Status:
UNKNOWN
Observational Registry on Patients With Endogenous CS to Document Safety and Effectiveness of Ketoconazole.
Lead Sponsor:
HRA Pharma
Conditions:
Cushing Syndrome
Eligibility:
All Genders
12+ years
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: ERC...
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...
Eligibility Criteria
Inclusion
- Male or female patients aged from 12 years or older with a diagnosis of CS
- Patients who started ketoconazole therapy after study start
- For patients previously treated with ketoconazole, patients must have taken their last dose at least 6 months before starting ketoconazole again in this study.
- Written informed consent signed prior to registration of any patient data in HRA modules.
Exclusion
- Adrenal cortical carcinoma
- Patients currently participating in any other trial (interventional or not) of an investigational medicine or participation in the past one month before start of ketoconazole
- Patients who have at least one contraindication among those listed in section 4.3 of the ketoconazole SmPC
Key Trial Info
Start Date :
December 20 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04872920
Start Date
December 20 2018
End Date
March 1 2024
Last Update
August 30 2022
Active Locations (6)
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1
University Hospital Zagreb
Zagreb, Croatia
2
Hôpital Universitaire Grenoble
Grenoble, France
3
Hôpital Bicêtre APHP
Le Kremlin-Bicêtre, France
4
Hôpital de la Conception
Marseille, France