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

Cushing Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03379363
• Other study ID #: C1073-900
• Status: Terminated
• Start date: September 18, 2017
• Est. completion date: February 12, 2018

Study information

• Verified date: July 2019
• Source: Corcept Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: February 12, 2018
• Est. primary completion date: February 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Adrenocortical Hyperfunction
• Cushing Syndrome
• Hypercortisolism
• Syndrome

Locations

Country	Name	City	State
United States	Corcept Therapeutics	Menlo Park	California

Sponsors (1)

Lead Sponsor	Collaborator
Corcept Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug utilization patterns as assessed by chart review	The retrospective review would analyze the drug utilization patterns of pediatric patients treated with Korlym	Length of Korlym therapy, up to 5 years
Secondary	Weight as assessed by chart review	The retrospective review would analyze changes in Weight (in kg) in pediatric patients treated with Korlym	Length of Korlym therapy, up to 5 years
Secondary	Blood Pressure as assessed by chart review	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