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

Primary Purpose

Essential Thrombocythaemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Anagrelide
Hydroxyurea
Sponsored by
AOP Orphan Pharmaceuticals AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Essential Thrombocythaemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Center Innsbruck
  • Center AKH
  • Center Hanusch
  • Center Brno
  • Center Olomouc
  • Center Praha
  • Center Paris
  • Center Munich
  • Center Berlin
  • Center Halle
  • Center Saarbrücken
  • Center Ulm
  • Center Budapest
  • Center Modena
  • Center Pavia
  • Center Vilnius
  • Center Gdansk
  • Center Katowice
  • Center Krakow
  • Center Lodz
  • Center Lublin
  • Center Warszawa
  • Center Singapore
  • Center Ljubljana

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Anagrelide

Hydroxyurea

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 8, 2010
Last Updated
October 5, 2010
Sponsor
AOP Orphan Pharmaceuticals AG
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1. Study Identification

Unique Protocol Identification Number
NCT01065038
Brief Title
Anagrelide vs. Hydroxyurea - Efficacy and Tolerability Study in Patients With Essential Thrombocythaemia
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
AOP Orphan Pharmaceuticals AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Thrombocythaemia

7. Study Design

Study Phase
Phase 3

8. Arms, Groups, and Interventions

Arm Title
Anagrelide
Arm Type
Experimental
Arm Title
Hydroxyurea
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Anagrelide
Intervention Type
Drug
Intervention Name(s)
Hydroxyurea

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
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 Information:
Facility Name
Center Innsbruck
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
Facility Name
Center AKH
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Center Hanusch
City
Vienna
ZIP/Postal Code
1140
Country
Austria
Facility Name
Center Brno
City
Brno
ZIP/Postal Code
62500
Country
Czech Republic
Facility Name
Center Olomouc
City
Olomouc
ZIP/Postal Code
77520
Country
Czech Republic
Facility Name
Center Praha
City
Prague
ZIP/Postal Code
12808
Country
Czech Republic
Facility Name
Center Paris
City
Paris
State/Province
CLICHY Cedex
ZIP/Postal Code
92118
Country
France
Facility Name
Center Munich
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80331
Country
Germany
Facility Name
Center Berlin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Center Halle
City
Halle
ZIP/Postal Code
06111
Country
Germany
Facility Name
Center Saarbrücken
City
Saarbrücken
ZIP/Postal Code
66113
Country
Germany
Facility Name
Center Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Center Budapest
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Center Modena
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Center Pavia
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Center Vilnius
City
Vilnius
ZIP/Postal Code
2600
Country
Lithuania
Facility Name
Center Gdansk
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Center Katowice
City
Katowice
ZIP/Postal Code
40-027
Country
Poland
Facility Name
Center Krakow
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Center Lodz
City
Lodz
ZIP/Postal Code
93-510
Country
Poland
Facility Name
Center Lublin
City
Lublin
ZIP/Postal Code
20-079
Country
Poland
Facility Name
Center Warszawa
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Center Singapore
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Center Ljubljana
City
Ljubljana
Country
Slovenia

12. IPD Sharing Statement

Citations:
PubMed Identifier
23315161
Citation
Gisslinger H, Gotic M, Holowiecki J, Penka M, Thiele J, Kvasnicka HM, Kralovics R, Petrides PE; ANAHYDRET Study Group. Anagrelide compared with hydroxyurea in WHO-classified essential thrombocythemia: the ANAHYDRET Study, a randomized controlled trial. Blood. 2013 Mar 7;121(10):1720-8. doi: 10.1182/blood-2012-07-443770. Epub 2013 Jan 11.
Results Reference
derived

Learn more about this trial

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

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