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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ingrid Pabinger, MD
• Collaborator: GlaxoSmithKline
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

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