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

NCT ID: NCT00888901

Last Updated: 2012-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2011-05-31

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.

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).

Conditions

Idiopathic Thrombocytopenic Purpura

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1

Patients on eltrombopag

Group Type: EXPERIMENTAL

eltrombopag

Intervention Type: DRUG

eltrombopag tablets daily, in increasing dosage, for three months

2

Patients on corticosteroids

Group Type: ACTIVE_COMPARATOR

corticosteroids (Aprednislon)

Intervention Type: DRUG

corticosteroids in decreasing dosage

3

Untreated patients

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

eltrombopag

eltrombopag tablets daily, in increasing dosage, for three months

Intervention Type: DRUG

corticosteroids (Aprednislon)

corticosteroids in decreasing dosage

Intervention Type: DRUG

Other Intervention Names

SB-497115-GR, Promacta (USA), Revolade (EU); Aprednislon

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Ingrid Pabinger, MD

OTHER

Sponsor Role: lead

Responsible Party

Ingrid Pabinger, MD

Univ.-Prof. Dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ingrid Pabinger, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

References

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.

Reference Type: DERIVED

PMID: 23389750 (View on PubMed)

Related Links

http://www.meduniwien.ac.at/haematology/

Division of hematology and hemostaseology, Med. Univ. Vienna

Other Identifiers

Eltrombopag 112650

Identifier Type: -

Identifier Source: secondary_id

IP-001

Identifier Type: -

Identifier Source: org_study_id