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.
- Conditions
- The refractory Cushing syndrome and subclinical Cushing syndrome.
- Registration Number
- JPRN-UMIN000024482
- Lead Sponsor
- Kyushu University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 16
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method