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

Cushing Syndrome Clinical Trial

— KetoPASS  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04872920
• Other study ID #: Keto PASS
• Status: Recruiting
• Start date: December 20, 2018
• Est. completion date: March 1, 2024

Study information

• Verified date: August 2022
• Source: HRA Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cushing Syndrome
• Syndrome

Locations

Country	Name	City	State
Croatia	University Hospital Zagreb	Zagreb
France	Hôpital Universitaire Grenoble	Grenoble
France	Hôpital Bicêtre APHP	Le Kremlin-Bicêtre
France	Hôpital de la Conception	Marseille
Spain	Institut de Recerca de la Santa Creu i Sant Pau	Barcelona
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
HRA Pharma

Countries where clinical trial is conducted

Croatia,  France,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 5 years of follow up
Secondary	Number of patients with adverse events	Number of adverse events with Ketoconazole in monotherapy or in combination with other therapies for Cushing Syndrome.	up to 5 years of follow up
Secondary	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	up to 5 years of follow up
Secondary	Drug utilization pattern of ketoconazole according to HRA SmPC recommendations on liver function	Timing of liver tests performed per patient according to defined windows.	up to 5 years of follow up
Secondary	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	up to 5 years of follow up
Secondary	Drug 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	up to 5 years of follow up
Secondary	Drug utilization pattern of ketoconazole according to HRA SmPC recommendations on Qt interval monitoring.	Timing of ECGs performed per patient according to defined windows	up to 5 years of follow up
Secondary	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	up to 5 years of follow up
Secondary	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.	up to 5 years of follow up
Secondary	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).	up to 5 years of follow up
Secondary	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.	up to 5 years of follow up