A Study of Anagrelide and Hydroxyurea in High-Risk Essential Thrombocythemia Patients

PHASE4CompletedINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

January 13, 2006

Primary Completion Date

December 15, 2015

Study Completion Date

December 15, 2015

Conditions
Thrombocythemia, Hemorrhagic
Interventions
DRUG

Anagrelide

Anagrelide hydrochloride 0.5mg capsules;initial dose administered will be 1.0mg/day administered as 0.5mg bid. The dose will be titrated such that the total daily dose is incremented by no more than 0.5mg per week as required depending on platelet reduction versus adverse event profile.

DRUG

Hydroxyurea

Hydroxyurea is 500mg hydroxycarbamide capsules; initial dose is 1000mg/day, administered in two divided doses (500mg/dose). Dose titrated to effect to achieve a response.

Trial Locations (15)

1303

University Multiprofile Hospital for active Treatment ''Alexandrovska'' Clinic of Haematology, Sofia

4012

University of Debrecen Medical and Health Science Centre, Debrecen

5700

Pandy Kalman Hospital of Bekes County, Gyula

5800

University Multiprofile Hospital for Active Treatment ''Dr Georgi Stranski'' - Pleven, Pleven

7400

Kaposi Mor Teaching Hospital, Kaposvár

9010

University Multiprofile Hospital for Active Treament ''Sv. Marina'' - Varna Haematology Clinic, Varna

9024

Petz Aladar County Teaching Hospital, Győr

11000

Institute for Haematology of Clinical Centre of Serbia, Belgrade

49933

CHU Angers Services des Maladies du Sang, Angers

Unknown

Hopital Saint Louis - Centre d'Investigation Clinique, Paris

80-952

Uniwersyteckie Centrum Kliniczne Katedra i Klinika Hematologii i Transplantologii, Gdansk

21-081

Samodzielny Publiczny Szpital Kliniczny Nr 1, Lublin

02-097

Katedra i Klinika Onkologii i Chorob Wewnetrznych Akademii Medycznej, Warsaw

02-776

Klinika Hematologii Instytut Hematologii i Transfuzjologi, Warsaw

3000-076

Hospitals da Universidade de Coimbra, Coimbra

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Shire

INDUSTRY