Status:
UNKNOWN
Phase II Trial of Romiplostim With Danazol in Patients With Eltrombopag-resistant Immune Thrombocytopenia
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Kyowa Kirin Korea Co., Ltd.
Conditions:
Immune Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In this study, we tried to demonstrate clinical benefit of additive danazol to romiplostim therapy in patients with eltrombopag-resistant immune thrombocytopenia
Detailed Description
The patients with eltrombopag-resistant immune thrombocytopenia are treated with romiplostim and danazol. The efficacy and toxicity of treatment will be evaluated.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2021
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04289207
Start Date
March 1 2020
End Date
March 1 2021
Last Update
February 28 2020
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