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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Ingrid Pabinger, MD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00888901
First received: April 27, 2009
Last updated: April 19, 2012
Last verified: April 2012

April 27, 2009
April 19, 2012
May 2009
March 2011   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
The shear-induced platelet activation (SC) is considered as the primary outcome measure. [ Time Frame: When patient has a platelet count between 50,000 and 100,000/µL. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00888901 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: No ]
Rise of reticulated platelets and variation of platelet antibodies. [ Time Frame: When patient has a platelet count between 50,000 and 100,000/µL. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Platelet Function in Idiopathic Thrombocytopenic Purpura (ITP) Patients With Eltrombopag
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 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).

Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Idiopathic Thrombocytopenic Purpura
  • Drug: eltrombopag
    eltrombopag tablets daily, in increasing dosage, for three months
    Other Name: SB-497115-GR, Promacta (USA), Revolade (EU)
  • Drug: corticosteroids (Aprednislon)
    corticosteroids in decreasing dosage
    Other Name: Aprednislon
  • Experimental: 1
    Patients on eltrombopag
    Intervention: Drug: eltrombopag
  • Active Comparator: 2
    Patients on corticosteroids
    Intervention: Drug: corticosteroids (Aprednislon)
  • No Intervention: 3
    Untreated patients
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
May 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00888901
IP-001, Eltrombopag 112650
No
Ingrid Pabinger, MD, Medical University of Vienna
Ingrid Pabinger, MD
GlaxoSmithKline
Principal Investigator: Ingrid Pabinger, Prof. Dr. Medical University of Vienna
Medical University of Vienna
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP