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

February 26, 2020 updated by: Youngil Koh, Seoul National University Hospital
In this study, we tried to demonstrate clinical benefit of additive danazol to romiplostim therapy in patients with eltrombopag-resistant immune thrombocytopenia

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

55

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: week 8
proportion of patients with platelet count over 50x10^9/L
week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to best response
Time Frame: week 24
time interval between initiation of treatment and best response
week 24
Response duration
Time Frame: week 24
period of time with platelet count over 50x10^9/L
week 24
Effects on quality of life
Time Frame: week 24
changes in EORTC QLQ-C30 scores
week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Kyowa Kirin Korea Co., Ltd.

Investigators

  • Principal Investigator: Youngil Koh, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2020

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

February 25, 2020

First Submitted That Met QC Criteria

February 26, 2020

First Posted (Actual)

February 28, 2020

Study Record Updates

Last Update Posted (Actual)

February 28, 2020

Last Update Submitted That Met QC Criteria

February 26, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0620200130

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Immune Thrombocytopenia

Clinical Trials on Romiplostim and danazol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe