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TerminatedNCT03379363Updated Jul 30, 2019

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

An observational study in Hypercortisolism and Cushing Syndrome, sponsored by Corcept Therapeutics. Terminated at 1 site in United States. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2019-07-30.

Sponsored by Corcept Therapeutics · Observational

Why this study was terminated
Insufficient number of patients
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
2
Ages
Up to 21 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hypercortisolism
  • Cushing Syndrome

Keywords

  • cushing syndrome, hypercortisolism
03

Who can participate

Ages eligible
Up to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pediatric patients who have been treated with Korlym for Cushing's syndrome

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

Exclusion Criteria:

  • None
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
2 participants (actual)
Patient registry
No

Groups and cohorts

  • Pediatric Cushing Syndrome Patients

    Pediatrics patients with endogenous Cushing syndrome who received at least one dose of Korlym

05

What researchers measure

Primary outcomes

  1. Drug utilization patterns as assessed by chart review

    The retrospective review would analyze the drug utilization patterns of pediatric patients treated with Korlym

    Time frame: Length of Korlym therapy, up to 5 years

Secondary outcomes

  1. Weight as assessed by chart review

    The retrospective review would analyze changes in Weight (in kg) in pediatric patients treated with Korlym

    Time frame: Length of Korlym therapy, up to 5 years

  2. Blood Pressure as assessed by chart review

    The retrospective review would analyze changes in Blood Pressure (in mmHg) in pediatric patients treated with Korlym

    Time frame: Length of Korlym therapy, up to 5 years

06

Study locations

1 site
  • Corcept Therapeutics
    Menlo Park, California 94025, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03379363
Lead sponsor
Corcept Therapeutics
Responsible party
Sponsor
First posted
Dec 20, 2017
Start date
Sep 18, 2017
Primary completion
Feb 12, 2018
Completion
Feb 12, 2018
Last update
Jul 30, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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