Anagrelide vs. Hydroxyurea - Efficacy and Tolerability Study in Patients With Essential Thrombocythaemia

AOP Orphan Pharmaceuticals AG

Overview

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.

Study Type

INTERVENTIONAL

Conditions

Essential Thrombocythaemia

Interventions

AnagrelideDRUG

HydroxyureaDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (24)

Center Innsbruck

Innsbruck, Tyrol, Austria

Center AKH

Vienna, Vienna, Austria

Data from ClinicalTrials.gov

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