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.

HRA Pharma6 sites in 4 countries200 target enrollmentDecember 20, 2018

ConditionsCushing Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cushing Syndrome
Sponsor: HRA Pharma
Enrollment: 200
Locations: 6
Primary Endpoint: incidence of hepatotoxicity and QT prolongation to assess liver and cardiac tolerability profile of ketoconazole.
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 20, 2018

End Date

March 1, 2024

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

HRA Pharma

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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

Outcomes

Primary Outcomes

incidence of hepatotoxicity and QT prolongation to assess liver and cardiac tolerability profile of ketoconazole.

Time Frame: up to 5 years of follow up

The primary objective is to document liver and cardiac tolerability profile of ketoconazole p.o when administered as monotherapy or in combination with other therapies, in routine clinical practice, in patients with CS.

Secondary Outcomes

Impact on Quality of life, European Quality of Life questionnaire(up to 5 years of follow up)
Drug utilization pattern regarding safe use of ketoconazole according to HRA SmPC recommendations on Qt interval monitoring.(up to 5 years of follow up)
Number of patients with adverse events(up to 5 years of follow up)
Drug utilization pattern regarding safe utilization of ketoconazole according to HRA SmPC recommendations on liver function(up to 5 years of follow up)
Drug utilization pattern of ketoconazole according to HRA SmPC recommendations on Qt interval monitoring.(up to 5 years of follow up)
Effectiveness of ketoconazole(up to 5 years of follow up)
Impact on Quality of life, Cushing Quality of Life questionnaire(up to 5 years of follow up)
Drug utilization pattern regarding safe use of ketoconazole according to HRA SmPC recommendations on liver function(up to 5 years of follow up)
Drug utilization pattern regarding safe utilization of ketoconazole according to HRA SmPC recommendations on Qt interval monitoring.(up to 5 years of follow up)
Drug utilization pattern of ketoconazole according to HRA SmPC recommendations on liver function(up to 5 years of follow up)