Observational Registry on Patients With Endogenous CS to Document Safety and Effectiveness of Ketoconazole. (KetoPASS)

HRA Pharma

Status: Enrolling

Conditions: Cushing Syndrome

Study type: Observational

Funder types: Industry

Identifiers

NCT04872920

Keto PASS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female patients aged from 12 years or older with a diagnosis of CS
2. Patients who started ketoconazole therapy after study start
3. For patients previously treated with ketoconazole, patients must have taken their last dose at least 6 months before starting ketoconazole again in this study.
4. Written informed consent signed prior to registration of any patient data in HRA modules.

Exclusion criteria

1. Adrenal cortical carcinoma
2. 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
3. Patients who have at least one contraindication among those listed in section 4.3 of the ketoconazole SmPC