Platelet Function in Idiopathic Thrombocytopenic Purpura (ITP) Patients With Eltrombopag (PLATEFUN)

April 19, 2012 updated by: Ingrid Pabinger, MD

Assessment of Platelet Function in Patients With Chronic Autoimmune Thrombocytopenic Purpura (cAITP) Treated With the Thrombopoietin Receptor (MPL) Agonist Eltrombopag.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

STUDY DESIGN:

Single-center (Medical University Vienna), prospective, controlled study. Patients will be recruited at the Division of Haematology and Haemostaseology at the Medical University in Vienna, one eltrombopag treatment group and 2 control groups, one on standard steroid treatment, another one untreated.

AIM OF THE STUDY:

To determine the effect of MPL agonists on shear-induced platelet activation. Data obtained from patients treated with eltrombopag shall be compared to those from untreated patients and patients on steroids. These investigations will extend previous studies that investigated platelet function without in vitro activation in patients receiving eltrombopag.

PATIENTS:

Trial Population:

Total number of patients n=34: 12 on eltrombopag, 12 on corticosteroids and 10 without treatment will be included in this trial.

Treatment with eltrombopag or corticosteroids. Eltrombopag starting dose: 25 mg/day, increased as needed (to 50 mg or maximum 75 mg once daily) every 2 weeks to reach a platelet count between 50,000-100000/µL and tapering the dosis if platelet count >= 100,000/µL. Afterwards, if platelet count stable (tolerance +/- 20%), platelet control every 4 weeks, otherwise weekly.

Prednisolone starting dose: 1 mg/kg/day to reach a platelet count between 50,000-100,000 /µL tapering of the dosage if platelet count >= 100,000/µL.

Laboratory Investigations:

In the eltrombopag group and in the newly treated prednisolone group platelet counts and platelet function tests will be performed at planned visits.

In patients who are on continuous corticosteroids (part of control group I) and untreated patients (control group II), which have a platelet count between 50,000 and 100,000/µL platelet counts, reticulated platelets, platelet function tests and platelet antibodies will be studied at entry and after 4 weeks (+ 5 days).

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

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 to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria (for all groups):

  • 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

Inclusion Criteria (for patients treated with eltrombopag):

  • Platelet count < 50,000 /µL at screening
  • At least one prior alternative cITP therapy

Inclusion Criteria (for patients treated with corticosteroids - Control group 1):

  • Platelet count < 50,000 /µL in history
  • At least 50% of the patients should have < 50,000 /µL at inclusion and should be followed for 3 months

Inclusion Criteria (for patients untreated - Control group 2):

  • Platelet count < 50,000 /µL in history
  • At screening platelet count between 50,000 and 100,000 /µL

Exclusion Criteria (for all patients):

  • 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

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: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Patients on eltrombopag
Drug: eltrombopag
eltrombopag tablets daily, in increasing dosage, for three months
Other Names:
  • SB-497115-GR, Promacta (USA), Revolade (EU)
Active Comparator: 2
Patients on corticosteroids
Drug: corticosteroids (Aprednislon)
corticosteroids in decreasing dosage
Other Names:
  • Aprednislon
No Intervention: 3
Untreated patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The shear-induced platelet activation (SC) is considered as the primary outcome measure.
Time Frame: After an average of 2-4 weeks, when patient has a platelet count between 50,000 and 100,000/µL.
After an average of 2-4 weeks, when patient has a platelet count between 50,000 and 100,000/µL.

Secondary Outcome Measures

Outcome Measure
Time Frame
Rise of reticulated platelets and variation of platelet antibodies.
Time Frame: After an average of 2-4 weeks, when patient has a platelet count between 50,000 and 100,000/µL.
After an average of 2-4 weeks, when patient has a platelet count between 50,000 and 100,000/µL.

Collaborators and Investigators

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

Sponsor

Ingrid Pabinger, MD

Collaborators

GlaxoSmithKline

Investigators

  • Principal Investigator: Ingrid Pabinger, Prof. Dr., Medical University of Vienna

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

Helpful Links

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

May 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

April 27, 2009

First Submitted That Met QC Criteria

April 27, 2009

First Posted (Estimate)

April 28, 2009

Study Record Updates

Last Update Posted (Estimate)

April 20, 2012

Last Update Submitted That Met QC Criteria

April 19, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IP-001
  • Eltrombopag 112650

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.

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