Immune Thrombocytopenia
Conditions
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.
Interventions
DRUGRomiplostim and danazol
Treatment with romiplostim and danazol
Sponsors
Kyowa Kirin Korea Co., Ltd.
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | week 8 | proportion of patients with platelet count over 50x10\^9/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to best response | week 24 | time interval between initiation of treatment and best response |
| Response duration | week 24 | period of time with platelet count over 50x10\^9/L |
| Effects on quality of life | week 24 | changes in EORTC QLQ-C30 scores |
Contacts
Primary ContactYoungil Koh
Outcome results
None listed