UnknownNot Applicable

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

Croatia, France, Spain200 participantsStarted 2018-12-20

Plain-language 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.

Who can participate

Age range12 Years

SexALL

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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

What they're measuring

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

Timeframe: up to 5 years of follow up

Trial details

NCT IDNCT04872920

SponsorHRA Pharma

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-03-01

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