Cushing SyndromeKetoPASSNCT04872920
Observational Registry on Patients With Endogenous CS to Document Safety and Effectiveness of Ketoconazole.
An observational study of Cushing Syndrome, run by HRA Pharma at 6 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cushing Syndrome
- How many people
- 200 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 20 Dec 2018to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
France3 sites, 3 recruiting
- Recruiting
Hôpital Universitaire Grenoble
Grenoble
Susan Webb, Pr, +34-93-5565661, swebb@santpau.cat
- Recruiting
Hôpital Bicêtre APHP
Le Kremlin-Bicêtre
Susan Webb, Pr, +34-93-5565661, swebb@santpau.cat
- Recruiting
Hôpital de la Conception
Marseille
Susan Webb, Pr, +34-93-5565661, swebb@santpau.cat
Croatia1 site, 1 recruiting
- Recruiting
University Hospital Zagreb
Zagreb
susan Webb, +34-93-5565661, swebb@santpau.cat
Spain1 site, 1 recruiting
- Recruiting
Institut de Recerca de la Santa Creu i Sant Pau
Barcelona
Susan Webb, Pr, +34-93-5565661, swebb@santpau.cat
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Gothenburg
susan webb, Pr, +34-93-5565661, swebb@santpau.cat
About this study
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.
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.
Read the 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.
- Conditions
- Cushing Syndrome
- Medical subject headings
- Cushing Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 5 years of follow up
Secondary outcomes (10)
Number of patients with adverse events
Number of adverse events with Ketoconazole in monotherapy or in combination with other therapies for Cushing Syndrome.
Measured: 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
Measured: 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.
Measured: 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
Measured: up to 5 years of follow up
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: up to 5 years of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start20 Dec 2018
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cushing SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HRA Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872920
- Sponsor's protocol ID
- Keto PASS
- Acronym
- KetoPASS
- Status last verified
- Aug 2022
- First submitted
- 16 Feb 2021
- Last updated
- 30 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04872920
- Acronym / sponsor ID
- KetoPASS / Keto PASS
- Conditions
- Cushing Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- HRA PharmaIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
10 secondary outcomes
Number of patients with adverse events
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
Time frame: up to 5 years of follow up
Drug utilization pattern of ketoconazole according to HRA SmPC recommendations on liver function
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
Time frame: up to 5 years of follow up
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
Drug utilization pattern of ketoconazole according to HRA SmPC recommendations on Qt interval monitoring.
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.
Time frame: up to 5 years of follow up
Effectiveness of ketoconazole
Time frame: up to 5 years of follow up
Impact on Quality of life, European Quality of Life questionnaire
Time frame: up to 5 years of follow up
Impact on Quality of life, Cushing Quality of Life questionnaire
Time frame: up to 5 years of follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cushing Syndrome, run by HRA Pharma at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Croatia, Spain, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of hepatotoxicity and QT prolongation to assess liver and cardiac tolerability profile of ketoconazole. (time frame: up to 5 years of follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2022.