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

Last updated: October 5, 2010
Sponsor: AOP Orphan Pharmaceuticals AG
Overall Status: Completed

Phase

3

Condition

Platelet Disorders

Thrombosis

Treatment

N/A

Clinical Study ID

NCT01065038
AOP03007
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Presence of essential thrombocythaemia with high-risk profile.

Exclusion

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 toeither active or non-active ingredients

  • known lactose intolerance

  • cardiovascular diseases grade III-IV (Toxicity Criteria of the South West OncologyGroup, 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

Study Design

Study Start date:
September 01, 2002
Estimated Completion Date:

Connect with a study center

  • Center Innsbruck

    Innsbruck, Tirol 6020
    Austria

    Site Not Available

  • Center AKH

    Vienna, 1090
    Austria

    Site Not Available

  • Center Hanusch

    Vienna, 1140
    Austria

    Site Not Available

  • Center Brno

    Brno, 62500
    Czech Republic

    Site Not Available

  • Center Olomouc

    Olomouc, 77520
    Czech Republic

    Site Not Available

  • Center Praha

    Prague, 12808
    Czech Republic

    Site Not Available

  • Center Paris

    Paris, CLICHY Cedex 92118
    France

    Site Not Available

  • Center Munich

    Munich, Bavaria 80331
    Germany

    Site Not Available

  • Center Berlin

    Berlin, 12200
    Germany

    Site Not Available

  • Center Halle

    Halle, 06111
    Germany

    Site Not Available

  • Center Saarbrücken

    Saarbrücken, 66113
    Germany

    Site Not Available

  • Center Saarbrücken

    Saarbrücken, 66113
    Germany

    Site Not Available

  • Center Ulm

    Ulm, 89081
    Germany

    Site Not Available

  • Center Budapest

    Budapest, 1097
    Hungary

    Site Not Available

  • Center Modena

    Modena, 41100
    Italy

    Site Not Available

  • Center Pavia

    Pavia, 27100
    Italy

    Site Not Available

  • Center Vilnius

    Vilnius, 2600
    Lithuania

    Site Not Available

  • Center Gdansk

    Gdansk, 80-211
    Poland

    Site Not Available

  • Center Katowice

    Katowice, 40-027
    Poland

    Site Not Available

  • Center Krakow

    Krakow, 31-501
    Poland

    Site Not Available

  • Center Lodz

    Lodz, 93-510
    Poland

    Site Not Available

  • Center Lublin

    Lublin, 20-079
    Poland

    Site Not Available

  • Center Warszawa

    Warszawa, 02-097
    Poland

    Site Not Available

  • Center Singapore

    Singapore, 169608
    Singapore

    Site Not Available

  • Center Ljubljana

    Ljubljana,
    Slovenia

    Site Not Available

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