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

Essential Thrombocythaemia Clinical Trial

— ANAHYDRET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01065038
• Other study ID #: AOP03007
• Status: Completed
• Phase: Phase 3
• First received: February 8, 2010
• Last updated: October 5, 2010
• Start date: September 2002

Study information

• Verified date: September 2005
• Source: AOP Orphan Pharmaceuticals AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and Women
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

N/A

Related Conditions & MeSH terms

• Essential Thrombocythaemia
• Thrombocythemia, Essential
• Thrombocytosis

Intervention

Drug:
• Anagrelide

• Hydroxyurea

Locations

Country	Name	City	State
Austria	Center Innsbruck	Innsbruck	Tirol
Austria	Center AKH	Vienna
Austria	Center Hanusch	Vienna
Czech Republic	Center Brno	Brno
Czech Republic	Center Olomouc	Olomouc
Czech Republic	Center Praha	Prague
France	Center Paris	Paris	CLICHY Cedex
Germany	Center Berlin	Berlin
Germany	Center Halle	Halle
Germany	Center Munich	Munich	Bavaria
Germany	Center Saarbrücken	Saarbrücken
Germany	Center Ulm	Ulm
Hungary	Center Budapest	Budapest
Italy	Center Modena	Modena
Italy	Center Pavia	Pavia
Lithuania	Center Vilnius	Vilnius
Poland	Center Gdansk	Gdansk
Poland	Center Katowice	Katowice
Poland	Center Krakow	Krakow
Poland	Center Lodz	Lodz
Poland	Center Lublin	Lublin
Poland	Center Warszawa	Warszawa
Singapore	Center Singapore	Singapore
Slovenia	Center Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
AOP Orphan Pharmaceuticals AG

Countries where clinical trial is conducted

Austria,  Czech Republic,  France,  Germany,  Hungary,  Italy,  Lithuania,  Poland,  Singapore,  Slovenia,