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Trial record 4 of 46 for:    DANAZOL

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04289207
Recruitment Status : Not yet recruiting
First Posted : February 28, 2020
Last Update Posted : February 28, 2020
Kyowa Kirin Korea Co., Ltd.
Information provided by (Responsible Party):
Youngil Koh, 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

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Drug: Romiplostim and danazol Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Romiplostim With Danazol in Patients With Eltrombopag-resistant Immune Thrombocytopenia
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : March 1, 2021

Arm Intervention/treatment
Experimental: Romiplostim and danazol
Treatment group (romiplostim and danazol)
Drug: Romiplostim and danazol
Treatment with romiplostim and danazol

Primary Outcome Measures :
  1. Response rate [ Time Frame: week 8 ]
    proportion of patients with platelet count over 50x10^9/L

Secondary Outcome Measures :
  1. Time to best response [ Time Frame: week 24 ]
    time interval between initiation of treatment and best response

  2. Response duration [ Time Frame: week 24 ]
    period of time with platelet count over 50x10^9/L

  3. Effects on quality of life [ Time Frame: week 24 ]
    changes in EORTC QLQ-C30 scores

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04289207

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Contact: Youngil Koh 82-02-2072-7217

Sponsors and Collaborators
Seoul National University Hospital
Kyowa Kirin Korea Co., Ltd.
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Principal Investigator: Youngil Koh Seoul National University Hospital
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Responsible Party: Youngil Koh, Associate professor, Seoul National University Hospital Identifier: NCT04289207    
Other Study ID Numbers: 0620200130
First Posted: February 28, 2020    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Skin Manifestations
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs