Retrospective Chart Review Study of Korlym for the Treatment of ACTH Independent Cushing's Syndrome (RE-KLAIM)

May 30, 2023 updated by: Corcept Therapeutics
Chart review study to collect patient data from medical charts of patients who have been treated with Korlym® for the treatment of ACTH independent adrenal Cushing's Syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A retrospective, multi-center, chart review study to collect patient data from medical charts of patients who have been treated with Korlym® for the treatment of ACTH independent adrenal Cushing's Syndrome. Treatment with Korlym® will be a minimum 3 months in duration with follow-up of a minimum 3 months. Only sites that have been identified to have patients appropriate for this protocol will be invited to participate.

Study Type

Observational

Enrollment (Actual)

24

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

ACTH Independent Cushing's Syndrome patients treated with Korlym® mifepristone) as standard of care in clinical practice.

Description

Inclusion Criteria:

  • Diagnosed with ACTH independent endogenous Cushing's Syndrome
  • Available adrenal imaging prior to being treated with Korlym®
  • Treated with Korlym® and followed for at least 3 months (follow-up data should be available)

Exclusion Criteria:

  • Diagnosed with adrenocortical carcinoma
  • Participant in any clinical trial(s) during the observational period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug Utilization Patterns as assessed by chart review
Time Frame: up to 4 years
The retrospective review would analyze the drug utilization patterns of patients treated with Korlym
up to 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Outcomes as assessed by chart review
Time Frame: up to 4 years
The retrospective review would analyze outcomes measures (vitals, clinical assessments, etc) in patients treated with Korlym
up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corcept Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

January 8, 2016

First Submitted That Met QC Criteria

January 21, 2016

First Posted (Estimated)

January 26, 2016

Study Record Updates

Last Update Posted (Actual)

June 1, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C1073-450

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cushing's Syndrome

Clinical Trials on No intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe