EUCTR2008-006143-40-ATActive, not recruitingNot Applicable
Assessment of platelet function in patients with chronic autoimmune thrombocytopenic purpura (cAITP) treated with the thrombopoietin receptor (MPL) agonist Eltrombopag
Medizinische Universität Wien, Universitätsklinik Innere Medizin I0 sites30 target enrollmentStarted: November 12, 2008Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
Investigators
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