Investigator-initiated phase I/IIa clinical trial to assess the safety and efficacy of 11beta-HSD1 inhibitor in patients with the refractory Cushing syndrome and subclinical Cushing syndrome. - Investigator-initiated clinical trial for 11beta-HSD1 inhibitor.

Kyushu University Hospital0 sites16 target enrollmentNovember 12, 2016

Overview

Phase: 未知
Intervention: Not specified
Conditions: The refractory Cushing syndrome and subclinical Cushing syndrome.
Sponsor: Kyushu University Hospital
Enrollment: 16
Status: Not yet recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

November 12, 2016

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•Exclude the patients who correspond to any of the following 12 criteria. 1\) Patients with sever heart or blood diseases. 2\) Patient with a high degree of renal dysfunction (eGFR\<30mL/min/1\.73 m2\) 3\) Patients with liver dysfunction (AST or ALT\> 3x Upper limit ) 4\) Patients with acute or chronic infection that require treatment. 5\) Patients with autoimmune or allergy diseases that require treatment. 6\) Patients with present or a history of less than 5 years of malignancy with exception of ectopic ACTH syndrome. 7\) Patients receiving metyrapone or trilostane within 1 week or mitotane within 3 months before first dose of 11beta\-HSD1 inhibitor. 8\) Patients with a history of drug allergies that interfere with participation in the clinical trial. 9\) Patients with mental illness or its history that interfere with participation in the clinical trial. 10\) Pregnant women, nursing mothers, or patients who do not agree to contraception during study period. 11\) Patients participating in other clinical trial or clinical research and receiving the drug within 30 days before obtaining informed consent. 12\) Patients who are deemed to be inappropriate by investigator or sharing physician from a medical point of view.