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

NCT04872920 | Unknown

• 1 other identifier: Keto PASS
• Study Type: observational
• Target: 200
• Locations: 4 countries
• Sites: 6

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.

Conditions

Cushing Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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 liver function

  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

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include all patients aged 12 years and above with endogenous CS from all causes exposed to ketoconazole and included by the participating centers in ERCUSYN. Patients with CS due to an adrenal carcinoma will be excluded from the study population since adrenal carcinoma is excluded from ERCUSYN registry.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• HRA Pharma: lead

Study Sites (6)

University Hospital Zagreb

Zagreb, Croatia

RECRUITING

Hôpital Universitaire Grenoble

Grenoble, France

RECRUITING

Hôpital Bicêtre APHP

Le Kremlin-Bicêtre, France

RECRUITING

Hôpital de la Conception

Marseille, France

RECRUITING

Institut de Recerca de la Santa Creu i Sant Pau

Barcelona, Spain

RECRUITING

Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

MeSH Terms

Conditions

Cushing Syndrome

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: May 5, 2021
• Study Start: December 20, 2018
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2024
• Last Updated: August 30, 2022

Record last verified: 2022-08

Locations

CR (1); FR (3); ES (1); SE (1)