Phase II Trial of Romiplostim With Danazol in Patients Wi... | NCT04289207

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

NCT04289207

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Feb 28, 2020Actual

Enrollment

55Estimated

Phase

Phase 2

Conditions

Immune Thrombocytopenia

Interventions

Romiplostim and danazol

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2020Estimated

Primary Completion Date

Sep 1, 2020Estimated

Completion Date

Mar 1, 2021Estimated

First Submitted Date

Feb 25, 2020

First Submission Date that Met QC Criteria

Feb 26, 2020

First Posted Date

Feb 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2020

Last Update Posted Date

Feb 28, 2020Actual

Name	Class
Kyowa Kirin Korea Co., Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Romiplostim and danazol	Experimental	Treatment group (romiplostim and danazol)	Drug: Romiplostim and danazol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Romiplostim and danazol	Drug	Treatment with romiplostim and danazol	Romiplostim and danazol

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Time to best response	time interval between initiation of treatment and best response	week 24
Response duration	period of time with platelet count over 50x10^9/L

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Youngil Koh	Contact	82-02-2072-7217		go01@snu.ac.kr

Name	Affiliation	Role
Youngil Koh	Seoul National University Hospital	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16643442	Background	Cooper N, Bussel J. The pathogenesis of immune thrombocytopaenic purpura. Br J Haematol. 2006 May;133(4):364-74. doi: 10.1111/j.1365-2141.2006.06024.x.
18981291	Background	Bussel JB, Kuter DJ, Pullarkat V, Lyons RM, Guo M, Nichol JL. Safety and efficacy of long-term treatment with romiplostim in thrombocytopenic patients with chronic ITP. Blood. 2009 Mar 5;113(10):2161-71. doi: 10.1182/blood-2008-04-150078. Epub 2008 Nov 3.

ID	Term
D011696	Purpura, Thrombocytopenic
D011693	Purpura
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases

ID	Term
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds