Phase II Trial of Romiplostim With Danazol in Patients With Eltrombopag-resistant Immune Thrombocytopenia

• Status: Not yet recruiting
• Trial end date: 2021-03-01
• Target enrollment: 0
• Participant gender: All

Summary

In this study, we tried to demonstrate clinical benefit of additive danazol to romiplostim therapy in patients with eltrombopag-resistant immune thrombocytopenia

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborators: Kyowa Hakko Kirin Korea Co., Ltd.; Kyowa Kirin Korea Co., Ltd.
• Treatments: Danazol

Criteria

Inclusion Criteria:

• aged over 18 years

• diagnosed with immune thrombocytopenia (bone marrow examination is not necessary)

• failed to achieve platelet count over 50X10^9/L with eltrombopag

• ECOG performance status 0,1,2

• available to obtain informed consent

Exclusion Criteria:

• Hepatitis B or C carriers

• HIV positive patients

• diagnosed with systemic lupus erythematosus or other autoimmune disorders

• unable to intake orally or absorb through gastrointestinal tract

• pregnant or breast-feeding

• diagnosed with uncontrolled seizure or other neuropsychiatric disorders

• diagnosed with clinically significant cardiovascular events within 6 months or dyspnea on exertion evaluated to New York Heart Association Functional Classification III or IV

• diagnosed with clinically significant cerebrovascular disorders

• previously diagnosed or treated with thromboembolism

• current treating malignant diseases

• currently accompanied by uncontrolled infection or active bleeding

• with blood test results as follows; total bilirubin > 2xUNL(upper normal limit), AST/ALT > 1.5xUNL, creatinine > 1.5xUNL, glomerular filtration rate < 30ml/min/1.73m^2

• registered to other clinical trials for treatment of immune thrombocytopenia

• judged to be inappropriate for clinical trial by doctor in charge