Retrospective Chart Review Study of Pediatric Patients Treated With Korlym for Cushing Syndrome

Terminated

• Conditions: Cushing Syndrome; Hypercortisolism

• Registration Number: NCT03379363
• Lead Sponsor: Corcept Therapeutics

Brief Summary

This retrospective, multi-center, chart review study will collect patient data from medical charts of pediatric patients who have been treated with Korlym for Cushing's syndrome.

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 Timeline

• Study Start: 2017-09-18
• Study First Submitted: 2017-10-24
• Study First Submitted QC: 2017-12-18
• Study First Posted: 2017-12-20
• Primary Completion: 2018-02-12
• Study Completion: 2018-02-12
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-26
• Last Update Posted: 2019-07-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Drug utilization patterns as assessed by chart review	Length of Korlym therapy, up to 5 years	The retrospective review would analyze the drug utilization patterns of pediatric patients treated with Korlym

Secondary Outcome Measures

Name	Time	Method
Weight as assessed by chart review	Length of Korlym therapy, up to 5 years	The retrospective review would analyze changes in Weight (in kg) in pediatric patients treated with Korlym
Blood Pressure as assessed by chart review	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

Trial Locations

Locations (1)

Corcept Therapeutics; 🇺🇸 Menlo Park, California, United States