NCT01652599

Brief Summary

The purpose of this study is to determine the response rate and response duration with the combination of eltrombopag and high-dose dexamethasone

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

January 7, 2014

Status Verified

January 1, 2014

Enrollment Period

1 year

First QC Date

July 26, 2012

Last Update Submit

January 3, 2014

Conditions

Immune Thrombocytopenic Purpura

Keywords

EltrombopagDexamethasoneHigh-doseITP

Outcome Measures

Primary Outcomes (1)

  • Number of patients with sustained response after 6 months

    Number of patients with complete response at month 6

    6 months

Secondary Outcomes (2)

  • Number of patients with complete response at month 6

    month 6

  • Bleeding

    month 6

Study Arms (1)

Eltrombopag and dexamethasone

EXPERIMENTAL
Drug: Eltrombopag and dexamethasone

Interventions

Eltrombopag and dexamethasoneDRUG

Eltrombopag 50 mg PO days 5-32 Dexamethasone 40 mg PO days 1-4

Also known as: Revolade
Eltrombopag and dexamethasone

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically confirmed immune thrombocytopenic (IT) Platelet count less than 30,000/mm3 on two occasions. Platelets \>30000/mm3 with bleeding.
  • Less than seven days taking corticosteroids
  • Normal to increased numbers of megakaryocytes on bone marrow examination in patients ≥ 60 years
  • Subject is ≥ 18 years
  • Subject has signed and dated written informed consent.
  • No sepsis or fever
  • No active infection requiring therapy
  • No active chronic viral infection
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

You may not qualify if:

  • Performance status above or equal to 2.
  • Previous treatment with eltrombopag
  • Immunosuppressive treatment within the last month
  • Previous splenectomy
  • Presence of malignant haematological disease
  • Connective tissue disease
  • Autoimmune hemolytic anemia
  • Pregnancy and lactation
  • Not willing to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario "Dr. Jose E. Gonzalez" UANL

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (3)

  • Bussel JB, Provan D, Shamsi T, Cheng G, Psaila B, Kovaleva L, Salama A, Jenkins JM, Roychowdhury D, Mayer B, Stone N, Arning M. Effect of eltrombopag on platelet counts and bleeding during treatment of chronic idiopathic thrombocytopenic purpura: a randomised, double-blind, placebo-controlled trial. Lancet. 2009 Feb 21;373(9664):641-8. doi: 10.1016/S0140-6736(09)60402-5.

    PMID: 19231632BACKGROUND

  • Jenkins JM, Williams D, Deng Y, Uhl J, Kitchen V, Collins D, Erickson-Miller CL. Phase 1 clinical study of eltrombopag, an oral, nonpeptide thrombopoietin receptor agonist. Blood. 2007 Jun 1;109(11):4739-41. doi: 10.1182/blood-2006-11-057968. Epub 2007 Feb 27.

    PMID: 17327409BACKGROUND

  • Gomez-Almaguer D, Herrera-Rojas MA, Jaime-Perez JC, Gomez-De Leon A, Cantu-Rodriguez OG, Gutierrez-Aguirre CH, Tarin-Arzaga L, Hernandez-Reyes J, Ruiz-Arguelles GJ. Eltrombopag and high-dose dexamethasone as frontline treatment of newly diagnosed immune thrombocytopenia in adults. Blood. 2014 Jun 19;123(25):3906-8. doi: 10.1182/blood-2014-01-549360. Epub 2014 May 6.

    PMID: 24802773DERIVED

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

eltrombopagDexamethasone

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)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • David Gomez-Almaguer, MD

    Hospital Universitario Dr. Jose E. Gonzalez

    PRINCIPAL INVESTIGATOR

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
MD

Study Record Dates

First Submitted

July 26, 2012

First Posted

July 30, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2013

Study Completion

November 1, 2013

Last Updated

January 7, 2014

Record last verified: 2014-01

Locations

ME(1)