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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04872920
Recruitment Status : Recruiting
First Posted : May 5, 2021
Last Update Posted : June 25, 2021
Sponsor:
Information provided by (Responsible Party):
HRA Pharma

Study Description
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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.

Condition or disease
Cushing Syndrome

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Actual Study Start Date : December 20, 2018
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: up to 5 years of follow up ]
    Number of adverse events with Ketoconazole in monotherapy or in combination with other therapies for Cushing Syndrome.

  2. Drug utilization pattern regarding safe utilization of ketoconazole according to HRA SmPC recommendations on liver function [ Time Frame: up to 5 years of follow up ]

    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


  3. Drug utilization pattern of ketoconazole according to HRA SmPC recommendations on liver function [ Time Frame: up to 5 years of follow up ]
    Timing of liver tests performed per patient according to defined windows.

  4. Drug utilization pattern regarding safe use of ketoconazole according to HRA SmPC recommendations on liver function [ Time Frame: up to 5 years of follow up ]

    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


  5. Drug utilization pattern regarding safe utilization of ketoconazole according to HRA SmPC recommendations on Qt interval monitoring. [ Time Frame: up to 5 years of follow up ]
    Number of ECGs performed per patient Number of patients for whom ECGs were performed according to SmPC recommendations

  6. Drug utilization pattern of ketoconazole according to HRA SmPC recommendations on Qt interval monitoring. [ Time Frame: up to 5 years of follow up ]
    Timing of ECGs performed per patient according to defined windows

  7. Drug utilization pattern regarding safe use of ketoconazole according to HRA SmPC recommendations on Qt interval monitoring. [ Time Frame: up to 5 years of follow up ]
    Percentage of patients for whom ECGs were performed according to SmPC recommendations

  8. Effectiveness of ketoconazole [ Time Frame: up to 5 years of follow up ]
    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.

  9. Impact on Quality of life, European Quality of Life questionnaire [ Time Frame: up to 5 years of follow up ]

    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).


  10. Impact on Quality of life, Cushing Quality of Life questionnaire [ Time Frame: up to 5 years of follow up ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04872920


Locations
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Croatia
University Hospital Zagreb Recruiting
Zagreb, Croatia
Contact: susan Webb    +34-93-5565661    swebb@santpau.cat   
France
Hôpital Universitaire Grenoble Recruiting
Grenoble, France
Contact: Susan Webb, Pr    +34-93-5565661    swebb@santpau.cat   
Hôpital Bicêtre APHP Recruiting
Le Kremlin-Bicêtre, France
Contact: Susan Webb, Pr    +34-93-5565661    swebb@santpau.cat   
Hôpital de la Conception Recruiting
Marseille, France
Contact: Susan Webb, Pr    +34-93-5565661    swebb@santpau.cat   
Spain
Institut de Recerca de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain
Contact: Susan Webb, Pr    +34-93-5565661    swebb@santpau.cat   
Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden
Contact: susan webb, Pr    +34-93-5565661    swebb@santpau.cat   
Sponsors and Collaborators
HRA Pharma
More Information
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Responsible Party: HRA Pharma
ClinicalTrials.gov Identifier: NCT04872920    
Other Study ID Numbers: Keto PASS
First Posted: May 5, 2021    Key Record Dates
Last Update Posted: June 25, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cushing Syndrome
Syndrome
Disease
Pathologic Processes
 Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases