Assessment of platelet function in patients with chronic autoimmune thrombocytopenic purpura (cAITP) treated with the thrombopoietin receptor (MPL) agonist Eltrombopag

Active, not recruiting

Conditions: patients suffering from chronic autoimmune thrombocytopeniathe platelet function/activation will be investigatedthe rise of reticulated platelets and variation of platelet antibodies will be investigated

Registration Number: EUCTR2008-006143-40-AT

Lead Sponsor: Medizinische Universität Wien, Universitätsklinik Innere Medizin I

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: 30

Inclusion 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
Incluison 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 Elthrombopag any time before
-Patients treated with another investigational product within the last 3 months