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
  Purpose

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.


Condition Intervention Phase
Idiopathic Thrombocytopenic Purpura
Drug: eltrombopag
Drug: corticosteroids (Aprednislon)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Assessment of Platelet Function in Patients With Chronic Autoimmune Thrombocytopenic Purpura (cAITP) Treated With the Thrombopoietin Receptor (MPL) Agonist Eltrombopag.

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: May 2009
Study Completion Date: May 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients on eltrombopag
Drug: eltrombopag
eltrombopag tablets daily, in increasing dosage, for three months
Other Name: SB-497115-GR, Promacta (USA), Revolade (EU)
Active Comparator: 2
Patients on corticosteroids
Drug: corticosteroids (Aprednislon)
corticosteroids in decreasing dosage
Other Name: Aprednislon
No Intervention: 3
Untreated patients

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).

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888901

Sponsors and Collaborators
Ingrid Pabinger, MD
GlaxoSmithKline
Investigators
Principal Investigator: Ingrid Pabinger, Prof. Dr. Medical University of Vienna
  More Information

Additional Information:
No publications provided by Medical University of Vienna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ingrid Pabinger, MD, Univ.-Prof. Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00888901     History of Changes
Other Study ID Numbers: IP-001, Eltrombopag 112650
Study First Received: April 27, 2009
Last Updated: April 19, 2012
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
ITP
eltrombopag
platelet function
thrombocytopenia
Platelet function in patients with cAITP on eltrombopag

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 30, 2014