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

Seoul National University

Status and phase: Unknown; Phase 2

Conditions: Immune Thrombocytopenia

Treatments: Drug: Romiplostim and danazol

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04289207

0620200130

Details and patient eligibility

About

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

Full description

The patients with eltrombopag-resistant immune thrombocytopenia are treated with romiplostim and danazol. The efficacy and toxicity of treatment will be evaluated.

Enrollment: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Romiplostim and danazol

Experimental group

Description:

Treatment group (romiplostim and danazol)

Treatment:

Drug: Romiplostim and danazol