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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00888901
• Date of registration: 27/04/2009
• Prospective Registration: Yes
• Primary sponsor: Ingrid Pabinger, MD
• Public title: Platelet Function in Idiopathic Thrombocytopenic Purpura (ITP) Patients With Eltrombopag PLATEFUN
• Scientific title: Assessment of Platelet Function in Patients With Chronic Autoimmune Thrombocytopenic Purpura (cAITP) Treated With the Thrombopoietin Receptor (MPL) Agonist Eltrombopag.
• Date of first enrolment: May 2009
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00888901
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: Phase 4

Countries of recruitment

Austria

Contacts

• Name: Ingrid Pabinger, Prof. Dr.
• Affiliation: Medical University of Vienna

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 90 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Idiopathic Thrombocytopenic Purpura

Intervention(s)

Drug: corticosteroids (Aprednislon)

Drug: eltrombopag

Primary Outcome(s)

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.]

Secondary Outcome(s)

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.]

Secondary ID(s)

Eltrombopag 112650

IP-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

GlaxoSmithKline