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Clinical Trials/EUCTR2008-006143-40-AT
EUCTR2008-006143-40-AT
Active, not recruiting
Not 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 enrollmentNovember 12, 2008
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DrugsAprednisolon

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Medizinische Universität Wien, Universitätsklinik Innere Medizin I
Enrollment
30
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 12, 2008
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Medizinische Universität Wien, Universitätsklinik Innere Medizin I

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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