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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Essential Thrombocythaemia Blood Coagulation Disorders Blood Platelet Disorders Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Myeloproliferative Disorders Thrombocythemia, Essential Thrombocytosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Center AKH, Vienna, State of Vienna, Austria

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anagrelide

Drug

Hydroxyurea

Drug

Sponsors and collaborators

Lead sponsor

AOP Orphan Pharmaceuticals AG

Industry

Registry information

Official study 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

Acronym: ANAHYDRET

Important dates

Study start: 2002
First posted: Feb 9, 2010
Registry last updated: Oct 6, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed