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

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

Sponsors

Lead Sponsor: Seoul National University Hospital

Collaborator: Kyowa Kirin Korea Co., Ltd.

Source Seoul National University Hospital
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.

Overall Status Not yet recruiting
Start Date March 1, 2020
Completion Date March 1, 2021
Primary Completion Date September 1, 2020
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Response rate week 8
Secondary Outcome
Measure Time Frame
Time to best response week 24
Response duration week 24
Effects on quality of life week 24
Enrollment 55
Condition
Intervention

Intervention Type: Drug

Intervention Name: Romiplostim and danazol

Description: Treatment with romiplostim and danazol

Arm Group Label: Romiplostim and danazol

Eligibility

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Youngil Koh Principal Investigator Seoul National University Hospital
Overall Contact

Last Name: Youngil Koh

Phone: 82-02-2072-7217

Email: [email protected]

Verification Date

February 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Seoul National University Hospital

Investigator Full Name: Youngil Koh

Investigator Title: Associate professor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Romiplostim and danazol

Type: Experimental

Description: Treatment group (romiplostim and danazol)

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov