Status:
COMPLETED
Platelet Function in Idiopathic Thrombocytopenic Purpura (ITP) Patients With Eltrombopag
Lead Sponsor:
Ingrid Pabinger, MD
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Idiopathic Thrombocytopenic Purpura
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief 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...
Detailed Description
STUDY DESIGN: Single-center (Medical University Vienna), prospective, controlled study. Patients will be recruited at the Division of Haematology and Haemostaseology at the Medical University in Vien...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00888901
Start Date
May 1 2009
End Date
May 1 2011
Last Update
April 20 2012
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