A Single Blind, Multi-centre, Randomised Multinational Phase III Study to Compare the Efficacy and Tolerability of Anagrelide vs Hydroxyurea in Patients With Essential Thrombocythaemia
| Registry | NCT01065038, acronym ANAHYDRET |
|---|---|
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Sponsor | AOP Orphan Pharmaceuticals AG (Industry) |
| Conditions | Essential Thrombocythaemia |
| Interventions | Anagrelide, Hydroxyurea (Drug) |
| Dates | start 2002-09-01, first posted 2010-02-09, last updated 2010-10-06 |
| Locations | 24 sites in Austria, Czechia, France, Germany, Hungary, Italy, Lithuania, Poland and 2 more countries |
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All trials for Essential Thrombocythaemia All trials of Anagrelide All trials of Hydroxyurea
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Anagrelide | Experimental | Drug: Anagrelide | |
| Hydroxyurea | Active comparator | Drug: Hydroxyurea |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Center AKH | Vienna, State of Vienna | Austria | |
| Center Hanusch | Vienna, State of Vienna | Austria | |
| Center Innsbruck | Innsbruck, Tyrol | Austria | |
| Center Brno | Brno | Czechia | |
| Center Olomouc | Olomouc | Czechia | |
| Center Praha | Prague | Czechia | |
| Center Paris | Paris, Clichy Cedex | France | |
| Center Munich | Munich, Bavaria | Germany | |
| Center Berlin | Berlin | Germany | |
| Center Halle | Halle | Germany | |
| Center Saarbrücken | Saarbrücken | Germany | |
| Center Ulm | Ulm | Germany | |
| Center Budapest | Budapest | Hungary | |
| Center Modena | Modena | Italy | |
| Center Pavia | Pavia | Italy | |
| Center Vilnius | Vilnius | Lithuania | |
| Center Gdansk | Gdansk | Poland | |
| Center Katowice | Katowice | Poland | |
| Center Krakow | Krakow | Poland | |
| Center Lodz | Lodz | Poland | |
| Center Lublin | Lublin | Poland | |
| Center Warszawa | Warsaw | Poland | |
| Center Singapore | Singapore | Singapore | |
| Center Ljubljana | Ljubljana | Slovenia |