NCT00888901

Brief Summary

This is a single-center, prospective, controlled study with one eltrombopag treatment group and 2 control groups, one on standard steroid treatment, and another one untreated. The aim of the study is to determine the effect of Thrombopoietin Receptor (MPL) agonists on shear-induced platelet activation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2009

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

First Submitted

Initial submission to the registry

April 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 28, 2009

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

April 20, 2012

Status Verified

April 1, 2012

Enrollment Period

1.8 years

First QC Date

April 27, 2009

Last Update Submit

April 19, 2012

Conditions

Idiopathic Thrombocytopenic Purpura

Keywords

ITPeltrombopagplatelet functionthrombocytopeniaPlatelet function in patients with cAITP on eltrombopag

Outcome Measures

Primary Outcomes (1)

  • The shear-induced platelet activation (SC) is considered as the primary outcome measure.

    After an average of 2-4 weeks, when patient has a platelet count between 50,000 and 100,000/µL.

Secondary Outcomes (1)

  • Rise of reticulated platelets and variation of platelet antibodies.

    After an average of 2-4 weeks, when patient has a platelet count between 50,000 and 100,000/µL.

Study Arms (3)

1

EXPERIMENTAL

Patients on eltrombopag

Drug: eltrombopag

2

ACTIVE COMPARATOR

Patients on corticosteroids

Drug: corticosteroids (Aprednislon)

3

NO INTERVENTION

Untreated patients

Interventions

eltrombopagDRUG

eltrombopag tablets daily, in increasing dosage, for three months

Also known as: SB-497115-GR, Promacta (USA), Revolade (EU)
1
corticosteroids (Aprednislon)DRUG

corticosteroids in decreasing dosage

Also known as: Aprednislon
2

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients with an established chronic autoimmune thrombocytopenia (cAITP)
  • Age ≥ 18 and ≤ 90 years
  • Females, if not pregnant, not nursing and consenting to perform safe anti-contraception
  • Written consent before any study related procedure
  • Platelet count \< 50,000 /µL at screening
  • At least one prior alternative cITP therapy
  • Platelet count \< 50,000 /µL in history
  • Platelet count \< 50,000 /µL in history
  • At screening platelet count between 50,000 and 100,000 /µL

You may not qualify if:

  • History of venous or arterial thromboembolism or stroke
  • Known coronary heart disease or cardiac arrythmias
  • Known HIV or Hepatitis C infection
  • Impaired liver function defined as elevated ALT \> 1.5 UNL, bilirubin more than ULN, albumin less than normal value
  • Prothrombin time less than normal value
  • Elevated creatinine level (\> 1.3 ULN)
  • Unable/unwilling to follow protocol
  • Previous or active malignancy
  • Patients who have been included in any other study with eltrombopag any time before
  • Patients treated with another investigational product within the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Haselboeck J, Kaider A, Pabinger I, Panzer S. Function of eltrombopag-induced platelets compared to platelets from control patients with immune thrombocytopenia. Thromb Haemost. 2013 Apr;109(4):676-83. doi: 10.1160/TH12-07-0522. Epub 2013 Feb 7.

    PMID: 23389750DERIVED

Related Links

MeSH Terms

Conditions

Purpura, Thrombocytopenic, IdiopathicThrombocytopenia

Interventions

eltrombopagAdrenal Cortex HormonesMethylprednisolone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone AntagonistsPrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Ingrid Pabinger, Prof. Dr.

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Univ.-Prof. Dr.

Study Record Dates

First Submitted

April 27, 2009

First Posted

April 28, 2009

Study Start

May 1, 2009

Primary Completion

March 1, 2011

Study Completion

May 1, 2011

Last Updated

April 20, 2012

Record last verified: 2012-04