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

ClinicalTrials.gov ID

NCT04872920

Lead Sponsor

HRA PharmaINDUSTRY

Overall Status

Unknown status

Study Type

Observational

Enrollment

200Estimated

Last Update Posted

Aug 30, 2022Actual

Start Date

Dec 20, 2018Actual

Primary Completion Date

Mar 1, 2023Estimated

Completion Date

Mar 1, 2024Estimated

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.

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.

• Cushing Syndrome

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

HRA PharmaINDUSTRY

swebb@santpau.cat+34-93-5565661

swebb@santpau.cat+34-93-5565661

swebb@santpau.cat+34-93-5565661

swebb@santpau.cat+34-93-5565661

swebb@santpau.cat+34-93-5565661

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