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.
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.
Study Type
OBSERVATIONAL
Enrollment
200
University Hospital Zagreb
Zagreb, Croatia
RECRUITINGHôpital Universitaire Grenoble
Grenoble, France
RECRUITINGHôpital Bicêtre APHP
Le Kremlin-Bicêtre, France
incidence of hepatotoxicity and QT prolongation to assess liver and cardiac tolerability profile of ketoconazole.
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.
Time frame: up to 5 years of follow up
Number of patients with adverse events
Number of adverse events with Ketoconazole in monotherapy or in combination with other therapies for Cushing Syndrome.
Time frame: up to 5 years of follow up
Drug utilization pattern regarding safe utilization of ketoconazole according to HRA SmPC recommendations on liver function
Number of liver tests performed per patient Number of patients for whom LFTs were performed according to SmPC recommendations. Number of patients with reduction of ketoconazole dose following liver enzymes increase Number of patients with interruptions / definitive stop of ketoconazole following liver enzymes increase
Time frame: up to 5 years of follow up
Drug utilization pattern of ketoconazole according to HRA SmPC recommendations on liver function
Timing of liver tests performed per patient according to defined windows.
Time frame: up to 5 years of follow up
Drug utilization pattern regarding safe use of ketoconazole according to HRA SmPC recommendations on liver function
Percentage of patients for whom LFTs were performed according to SmPC recommendations. Percentage of patients with reduction of ketoconazole dose following liver enzymes increase Percentage of patients with interruptions / definitive stop of ketoconazole following liver enzymes increase
Time frame: up to 5 years of follow up
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Hôpital de la Conception
Marseille, France
RECRUITINGInstitut de Recerca de la Santa Creu i Sant Pau
Barcelona, Spain
RECRUITINGSahlgrenska University Hospital
Gothenburg, Sweden
RECRUITINGDrug utilization pattern regarding safe utilization of ketoconazole according to HRA SmPC recommendations on Qt interval monitoring.
Number of ECGs performed per patient Number of patients for whom ECGs were performed according to SmPC recommendations
Time frame: up to 5 years of follow up
Drug utilization pattern of ketoconazole according to HRA SmPC recommendations on Qt interval monitoring.
Timing of ECGs performed per patient according to defined windows
Time frame: up to 5 years of follow up
Drug utilization pattern regarding safe use of ketoconazole according to HRA SmPC recommendations on Qt interval monitoring.
Percentage of patients for whom ECGs were performed according to SmPC recommendations
Time frame: up to 5 years of follow up
Effectiveness of ketoconazole
clinical outcome evaluated by the physician after ketoconazole treatment: cortisol levels improvement or normalization after ketoconazole treatment clinical symptoms of Cushing Syndrome over time. Number and type of comorbidities. Number of concomitant treatments for comorbidities by drug class.
Time frame: up to 5 years of follow up
Impact on Quality of life, European Quality of Life questionnaire
self-administered questionnaire of Health-Related Quality of Life to evaluate current health regarding mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and the perceived health status of the patient. The answers given can be converted into utility scores anchored at 0 for death and 1 for perfect health. The questionnaire also includes a Vi-sual Analog Scale (VAS), by which respondents can reporttheir perceived health status with a grade ranging from 0(the worst possible health status) to 100 (the best possiblehealth status).
Time frame: up to 5 years of follow up
Impact on Quality of life, Cushing Quality of Life questionnaire
items referring to problems relevant to patients with CS with five categories of response. Answers are rated on a scale of 1-5, where '1' corresponds to 'Always' or 'Very much' and '5' to 'Never' or 'Not at all'. Therefore, the lower the score, the greater the impact on Health-Related Quality of Life.
Time frame: up to 5 years of follow up