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

• Sponsor: Corcept Therapeutics (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03379363
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Actual Duration (Months): 4.8
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypercortisolism; Cushing 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 Design

• Study Type: Observational
• Actual Enrollment: 2 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Retrospective Chart Review Study of Pediatric Patients Treated With Korlym for Cushing Syndrome
• Actual Study Start Date: Sep 18, 2017
• Actual Primary Completion Date: Feb 12, 2018
• Actual Study Completion Date: Feb 12, 2018

Arms and Interventions

Arm	Intervention/Treatment
Pediatric Cushing Syndrome Patients Pediatrics patients with endogenous Cushing syndrome who received at least one dose of Korlym

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 21 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Corcept Therapeutics	Menlo Park	California	United States	94025

Sponsors and Collaborators

• Corcept Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Corcept Therapeutics
• ClinicalTrials.gov Identifier: NCT03379363
• Other Study ID Numbers: C1073-900
• First Posted: Dec 20, 2017
• Last Update Posted: Jul 30, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Corcept Therapeutics: cushing syndrome, hypercortisolism
• Additional relevant MeSH terms: Cushing Syndrome; Adrenocortical Hyperfunction; Syndrome

Study Results

No Results Posted as of Jul 30, 2019