Essential Thrombocythaemia
Conditions
Brief summary
Study AOP 03-007 was designed as a pivotal study to test, if Anagrelide (Thromboreductin®)was not inferior to HU with respect to efficacy in patients with ET. This approach to demonstrate non-inferiority was based on the following decision points: • ET is a rare disease and recruitment of large patient number (\> 1600) to prove superiority was not considered possible. . It was decided to recruit only treatment naïve high risk patients to avoid pre-treatment bias, which further limited the number of patients eligible for the study.
Interventions
DRUGAnagrelide
DRUGHydroxyurea
Sponsors
AOP Orphan Pharmaceuticals AG
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Presence of essential thrombocythaemia with high-risk profile.
Exclusion criteria
* previous treatment with cytoreductive drugs or Anagrelide * pregnant women or women in childbearing age with inadequate contraception * patients with contraindications for study drugs due to anaphylactoid reactions to either active or non-active ingredients * known lactose intolerance * cardiovascular diseases grade III-IV (Toxicity Criteria of the South West Oncology Group, 1992) - with a negative benefit/risk ratio * severe renal disease (Creatinin Clearance \< 30 ml/min) * severe liver disease (AST or ALT \> 5-times normal) * coexisting, malignant, systemic diseases
Countries
Austria, Czechia, France, Germany, Hungary, Italy, Lithuania, Poland, Singapore, Slovenia
Outcome results
None listed