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

Phase 3

Completed

• Conditions: Essential Thrombocythaemia
• Interventions: Drug: Anagrelide; Drug: Hydroxyurea

• Registration Number: NCT01065038
• Lead Sponsor: AOP Orphan Pharmaceuticals AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Status Verified: 2005-09
• Study First Submitted: 2010-02-08
• Study First Submitted QC: 2010-02-08
• Study First Posted: 2010-02-09
• Last Update Submitted: 2010-10-05
• Last Update Posted: 2010-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anagrelide	Anagrelide	-
Hydroxyurea	Hydroxyurea	-

Trial Locations

Locations (24)

Center Munich; 🇩🇪 Munich, Bavaria, Germany

Center Olomouc; 🇨🇿 Olomouc, Czech Republic

Center Gdansk; 🇵🇱 Gdansk, Poland

Center Krakow; 🇵🇱 Krakow, Poland

Center Praha; 🇨🇿 Prague, Czech Republic

Center Lodz; 🇵🇱 Lodz, Poland

Center Ulm; 🇩🇪 Ulm, Germany

Center Modena; 🇮🇹 Modena, Italy

Center Paris; 🇫🇷 Paris, CLICHY Cedex, France

Center Brno; 🇨🇿 Brno, Czech Republic

Center Innsbruck; 🇦🇹 Innsbruck, Tirol, Austria

Center AKH; 🇦🇹 Vienna, Austria

Center Hanusch; 🇦🇹 Vienna, Austria

Center Halle; 🇩🇪 Halle, Germany

Center Berlin; 🇩🇪 Berlin, Germany

Center Budapest; 🇭🇺 Budapest, Hungary

Center Saarbrücken; 🇩🇪 Saarbrücken, Germany

Center Vilnius; 🇱🇹 Vilnius, Lithuania

Center Katowice; 🇵🇱 Katowice, Poland

Center Pavia; 🇮🇹 Pavia, Italy

Center Singapore; 🇸🇬 Singapore, Singapore

Center Lublin; 🇵🇱 Lublin, Poland

Center Warszawa; 🇵🇱 Warszawa, Poland

Center Ljubljana; 🇸🇮 Ljubljana, Slovenia