NCT00202644

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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_4

Geographic Reach
6 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
4 months until next milestone

Study Start

First participant enrolled

January 13, 2006

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2015

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

January 24, 2018

Completed
Last Updated

June 2, 2021

Status Verified

May 1, 2021

Enrollment Period

9.9 years

First QC Date

September 12, 2005

Results QC Date

October 13, 2016

Last Update Submit

May 13, 2021

Conditions

Thrombocythemia, Hemorrhagic

Outcome Measures

Primary Outcomes (2)

  • Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Over Time

    The LVEF was measured by echocardiography and considered a sufficiently sensitive measure to evaluate any changes in cardiac function.

    Baseline and Month 1, 2, 3, 6, 9, 12, 18, 24, 30 and 36

  • Platelet Count at Month 6

    Platelet count was evaluated.

    Month 6

Secondary Outcomes (8)

  • Change From Baseline in Platelet Counts at Month 3 and 36

    Baseline and Month 3 and 36

  • Percentage of Participants With Complete Response

    Baseline up to Month 36

  • Percentage of Participants With Partial Response

    Baseline up to Month 36

  • Time to Complete Response

    Baseline up to Month 36

  • Time to Partial Response

    Baseline up to Month 36

  • +3 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL
Drug: Anagrelide

B

ACTIVE COMPARATOR
Drug: Hydroxyurea

Interventions

AnagrelideDRUG

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.

A
HydroxyureaDRUG

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.

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

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

Pleven, 5800, Bulgaria

Location

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

Sofia, 1303, Bulgaria

Location

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

Varna, 9010, Bulgaria

Location

CHU Angers Services des Maladies du Sang

Angers, Cedex 09, 49933, France

Location

Hopital Saint Louis - Centre d'Investigation Clinique

Paris, France

Location

University of Debrecen Medical and Health Science Centre

Debrecen, 4012, Hungary

Location

Petz Aladar County Teaching Hospital

Győr, 9024, Hungary

Location

Pandy Kalman Hospital of Bekes County

Gyula, 5700, Hungary

Location

Kaposi Mor Teaching Hospital

Kaposvár, 7400, Hungary

Location

Uniwersyteckie Centrum Kliniczne Katedra i Klinika Hematologii i Transplantologii

Gdansk, 80-952, Poland

Location

Samodzielny Publiczny Szpital Kliniczny Nr 1

Lublin, 21-081, Poland

Location

Katedra i Klinika Onkologii i Chorob Wewnetrznych Akademii Medycznej

Warsaw, 02-097, Poland

Location

Klinika Hematologii Instytut Hematologii i Transfuzjologi

Warsaw, 02-776, Poland

Location

Hospitals da Universidade de Coimbra

Coimbra, 3000-076, Portugal

Location

Institute for Haematology of Clinical Centre of Serbia

Belgrade, 11000, Serbia

Location

Related Publications (2)

  • Birgegard G, Folkvaljon F, Garmo H, Holmberg L, Besses C, Griesshammer M, Gugliotta L, Wu J, Achenbach H, Kiladjian JJ, Harrison CN. Leukemic transformation and second cancers in 3649 patients with high-risk essential thrombocythemia in the EXELS study. Leuk Res. 2018 Nov;74:105-109. doi: 10.1016/j.leukres.2018.10.006. Epub 2018 Oct 11.

    PMID: 30368038RESULT

  • Gotic M, Egyed M, Gercheva L, Warzocha K, Kvasnicka HM, Achenbach H, Wu J. Cardiovascular Safety of Anagrelide Hydrochloride versus Hydroxyurea in Essential Thrombocythaemia. Cardiovasc Toxicol. 2021 Mar;21(3):236-247. doi: 10.1007/s12012-020-09615-0. Epub 2020 Oct 29.

    PMID: 33123978DERIVED

MeSH Terms

Conditions

Thrombocythemia, Essential

Interventions

anagrelideHydroxyurea

Condition Hierarchy (Ancestors)

Blood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombocytosisBlood Platelet DisordersMyeloproliferative DisordersBone Marrow DiseasesHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

UreaAmidesOrganic Chemicals

Results Point of Contact

Title
Study Director
Organization
Shire
ClinicalTransparency@shire.com
+1 866 842 5335

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

January 13, 2006

Primary Completion

December 15, 2015

Study Completion

December 15, 2015

Last Updated

June 2, 2021

Results First Posted

January 24, 2018

Record last verified: 2021-05

Locations

PL(4)PT(1)FR(2)BU(3)HU(4)SE(1)