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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00202644
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : January 24, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Shire

Brief Summary:
Essential thrombocythaemia is a disorder of bone marrow, which causes too many platelets to be produced. Platelets are small cells carried around in the blood, which help form blood clots. When patients have too many platelets, there is a risk of blood clots forming unnecessarily and excessive bleeding. The aim of this study is to gain additional information on the safety profile of Anagrelide (Xagrid(r)) and Hydroxyurea (also known as hydroxycarbamide).

Condition or disease Intervention/treatment Phase
Thrombocythemia, Hemorrhagic Drug: Anagrelide Drug: Hydroxyurea Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IIIb, Randomized, Open Label Study to Compare the Safety, Efficacy and Tolerability of Anagrelide Hydrochloride Versus Hydroxyurea in High-Risk Essential Thrombocythaemia Patients.
Actual Study Start Date : January 13, 2006
Actual Primary Completion Date : December 15, 2015
Actual Study Completion Date : December 15, 2015


Arm Intervention/treatment
Experimental: A 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.

Active Comparator: B 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.




Primary Outcome Measures :
  1. Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Over Time [ Time Frame: Baseline and Month 1, 2, 3, 6, 9, 12, 18, 24, 30 and 36 ]
    The LVEF was measured by echocardiography and considered a sufficiently sensitive measure to evaluate any changes in cardiac function.

  2. Platelet Count at Month 6 [ Time Frame: Month 6 ]
    Platelet count was evaluated.


Secondary Outcome Measures :
  1. Change From Baseline in Platelet Counts at Month 3 and 36 [ Time Frame: Baseline and Month 3 and 36 ]
    Platelet count was evaluated throughout the study.

  2. Percentage of Participants With Complete Response [ Time Frame: Baseline up to Month 36 ]
    A complete response was defined as a platelet count of less than (<) 400x10^9/Liter which was confirmed over 2 consecutive visits at least 28 days apart.

  3. Percentage of Participants With Partial Response [ Time Frame: Baseline up to Month 36 ]
    A partial response is defined as a platelet count of 400-600 x 10^9/Liter and a reduction in platelet count of at least 200 x 10^9/Liter from baseline which was confirmed over 2 consecutive visits at least 28 days apart.

  4. Time to Complete Response [ Time Frame: Baseline up to Month 36 ]
    Time in days from the date of the first dose of study medication to the date of the first visit at which response was classified. If a participant did not achieve response then they were censored at their last visit in the study (Month 36 or withdrawal).

  5. Time to Partial Response [ Time Frame: Baseline up to Month 36 ]
    Time in days from the date of the first dose of study medication to the date of the first visit at which response was classified. If a participant did not achieve response then they were censored at their last visit in the study (Month 36 or withdrawal).

  6. Number of Participants With Thrombotic and Haemorrhagic Events [ Time Frame: From the signing of informed consent until the last study-related visit (Month 36) ]
    Thrombohaemorrhagic events are a well-known complication of the underlying essential thrombocythemia (ET) and disease progression. Events such as arterial and venous thrombosis, serious haemorrhage (including gastrointestinal haemorrhage), and death from vascular causes have been reported in participants who received cytoreductive treatment.

  7. Change From Baseline in White Blood Cell Count Over Time [ Time Frame: Baseline and Month 6, 12, 18, 24, 30 and 36 ]
    White blood cell count was evaluated throughout the study.

  8. Change From Baseline in Red Blood Cell Count Over Time [ Time Frame: Baseline and Month 6, 12, 18, 24, 30 and 36 ]
    Red blood cell count was evaluated throughout the study.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of essential thrombocythaemia - high risk profile
  • Previously untreated with a cytoreductive agent
  • Females of childbearing potential must have a negative urine pregnancy test prior to entering the study and must agree to use effective birth control for the duration of the study

Exclusion Criteria:

  • Diagnosis of any other myeloproliferative disorder
  • Any known cause for a secondary thrombocytosis
  • Anti-coagulant and anti-aggregant therapies
  • Known or suspected heart disease
  • Left Ventricular Ejection Fraction < 55%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00202644


Locations
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Bulgaria
University Multiprofile Hospital for Active Treatment ''Dr Georgi Stranski'' - Pleven
Pleven, Bulgaria, 5800
University Multiprofile Hospital for active Treatment ''Alexandrovska'' Clinic of Haematology
Sofia, Bulgaria, 1303
University Multiprofile Hospital for Active Treament ''Sv. Marina'' - Varna Haematology Clinic
Varna, Bulgaria, 9010
France
CHU Angers Services des Maladies du Sang
Angers, Cedex 09, France, 49933
Hopital Saint Louis - Centre d'Investigation Clinique
Paris, France
Hungary
University of Debrecen Medical and Health Science Centre
Debrecen, Hungary, 4012
Petz Aladar County Teaching Hospital
Gyor, Hungary, 9024
Pandy Kalman Hospital of Bekes County
Gyula, Hungary, 5700
Kaposi Mor Teaching Hospital
Kaposvar, Hungary, 7400
Poland
Uniwersyteckie Centrum Kliniczne Katedra i Klinika Hematologii i Transplantologii
Gdansk, Poland, 80-952
Samodzielny Publiczny Szpital Kliniczny Nr 1
Lublin, Poland, 21-081
Katedra i Klinika Onkologii i Chorob Wewnetrznych Akademii Medycznej
Warsaw, Poland, 02-097
Klinika Hematologii Instytut Hematologii i Transfuzjologi
Warsaw, Poland, 02-776
Portugal
Hospitals da Universidade de Coimbra
Coimbra, Portugal, 3000-076
Serbia
Institute for Haematology of Clinical Centre of Serbia
Belgrade, Serbia, 11000
Sponsors and Collaborators
Shire
Investigators
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Study Director: Study Director Shire

Publications of Results:
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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00202644     History of Changes
Other Study ID Numbers: SPD422-403
2004-004061-15 ( EudraCT Number )
First Posted: September 20, 2005    Key Record Dates
Results First Posted: January 24, 2018
Last Update Posted: December 13, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
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Thrombocytosis
Thrombocythemia, Essential
Blood Platelet Disorders
Hematologic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Blood Coagulation Disorders
Hemorrhagic Disorders
Hydroxyurea
Anagrelide
Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Fibrinolytic Agents
Fibrin Modulating Agents
Platelet Aggregation Inhibitors