Idiopathic Thrombocytopenic Purpura Clinical Trial
— PLATEFUNOfficial title:
Assessment of Platelet Function in Patients With Chronic Autoimmune Thrombocytopenic Purpura (cAITP) Treated With the Thrombopoietin Receptor (MPL) Agonist Eltrombopag.
Verified date | April 2012 |
Source | Medical University of Vienna |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | May 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ingrid Pabinger, MD | GlaxoSmithKline |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The shear-induced platelet activation (SC) is considered as the primary outcome measure. | After an average of 2-4 weeks, when patient has a platelet count between 50,000 and 100,000/µL. | ||
Secondary | Rise of reticulated platelets and variation of platelet antibodies. | After an average of 2-4 weeks, when patient has a platelet count between 50,000 and 100,000/µL. |
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