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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: February 12, 2018

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.

Arms, Groups and Cohorts

  • Pediatric Cushing Syndrome Patients
    • Pediatrics patients with endogenous Cushing syndrome who received at least one dose of Korlym

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 21 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Corcept Therapeutics
  • Provider of Information About this Clinical Study
    • Sponsor

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