- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03379363
Retrospective Chart Review Study of Pediatric Patients Treated With Korlym for Cushing Syndrome
Study Overview
Status
Conditions
Detailed Description
This retrospective chart review study seeks to collect data from pediatric patients treated with Korlym (mifepristone) to help provide clinicians with some insight on the potential role of mifepristone in the treatment of pediatric patients with Cushing syndrome.
Only sites that have been identified to have patients appropriate for this protocol will be invited to participate and contribute data on their patients
Data to be collected from a retrospective chart review will include:
- Patient demographics
- Medical history
- Pre and post treatment clinical assessments and laboratory results
- Radiologic findings (if available)
- Adverse events
Data will be collected for all follow-up visits, up until the most recent encounter prior to IRB approval.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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California
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Menlo Park, California, United States, 94025
- Corcept Therapeutics
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Pediatrics (age≤21 years) at time Korlym initiation
- Considered to have a diagnosis of endogenous Cushing's syndrome by the healthcare provider
- Received at least one dose of Korlym
- Availability of pre-treatment (baseline) and follow-up data
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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Pediatric Cushing Syndrome Patients
Pediatrics patients with endogenous Cushing syndrome who received at least one dose of Korlym
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Drug utilization patterns as assessed by chart review
Time Frame: Length of Korlym therapy, up to 5 years
|
The retrospective review would analyze the drug utilization patterns of pediatric patients treated with Korlym
|
Length of Korlym therapy, up to 5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight as assessed by chart review
Time Frame: Length of Korlym therapy, up to 5 years
|
The retrospective review would analyze changes in Weight (in kg) in pediatric patients treated with Korlym
|
Length of Korlym therapy, up to 5 years
|
Blood Pressure as assessed by chart review
Time Frame: Length of Korlym therapy, up to 5 years
|
The retrospective review would analyze changes in Blood Pressure (in mmHg) in pediatric patients treated with Korlym
|
Length of Korlym therapy, up to 5 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C1073-900
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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