NCT04289207

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2020

Shorter than P25 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

6 months

First QC Date

February 25, 2020

Last Update Submit

February 26, 2020

Conditions

Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

  • Response rate

    proportion of patients with platelet count over 50x10\^9/L

    week 8

Secondary Outcomes (3)

  • Time to best response

    week 24

  • Response duration

    week 24

  • Effects on quality of life

    week 24

Study Arms (1)

Romiplostim and danazol

EXPERIMENTAL

Treatment group (romiplostim and danazol)

Drug: Romiplostim and danazol

Interventions

Romiplostim and danazolDRUG

Treatment with romiplostim and danazol

Romiplostim and danazol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 16643442BACKGROUND

  • 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.

    PMID: 18981291BACKGROUND

  • Wong RSM, Saleh MN, Khelif A, Salama A, Portella MSO, Burgess P, Bussel JB. Safety and efficacy of long-term treatment of chronic/persistent ITP with eltrombopag: final results of the EXTEND study. Blood. 2017 Dec 7;130(23):2527-2536. doi: 10.1182/blood-2017-04-748707. Epub 2017 Oct 17.

    PMID: 29042367BACKGROUND

  • Khellaf M, Viallard JF, Hamidou M, Cheze S, Roudot-Thoraval F, Lefrere F, Fain O, Audia S, Abgrall JF, Michot JM, Dauriac C, Lefort S, Gyan E, Niault M, Durand JM, Languille L, Boutboul D, Bierling P, Michel M, Godeau B. A retrospective pilot evaluation of switching thrombopoietic receptor-agonists in immune thrombocytopenia. Haematologica. 2013 Jun;98(6):881-7. doi: 10.3324/haematol.2012.074633. Epub 2013 Feb 26.

    PMID: 23445876BACKGROUND

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

romiplostimDanazol

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Youngil Koh

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Youngil Koh

CONTACT

82-02-2072-7217go01@snu.ac.kr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 25, 2020

First Posted

February 28, 2020

Study Start

March 1, 2020

Primary Completion

September 1, 2020

Study Completion

March 1, 2021

Last Updated

February 28, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share