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

Phase 4

Completed

• Conditions: Thrombocythemia, Hemorrhagic
• Interventions: Drug: Anagrelide; Drug: Hydroxyurea

• Registration Number: NCT00202644
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-20
• Study Start: 2006-01-13
• Primary Completion: 2015-12-15
• Study Completion: 2015-12-15
• Results First Submitted: 2016-10-13
• Results First Submitted QC: 2017-06-16
• Results First Posted: 2018-01-24
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-13
• Last Update Posted: 2021-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Anagrelide	-
B	Hydroxyurea	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Left Ventricular Ejection Fraction (LVEF) Over Time	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.
Platelet Count at Month 6	Month 6	Platelet count was evaluated.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Partial Response	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.
Change From Baseline in Red Blood Cell Count Over Time	Baseline and Month 6, 12, 18, 24, 30 and 36	Red blood cell count was evaluated throughout the study.
Change From Baseline in Platelet Counts at Month 3 and 36	Baseline and Month 3 and 36	Platelet count was evaluated throughout the study.
Percentage of Participants With Complete Response	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.
Time to Partial Response	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).
Number of Participants With Thrombotic and Haemorrhagic Events	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.
Time to Complete Response	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).
Change From Baseline in White Blood Cell Count Over Time	Baseline and Month 6, 12, 18, 24, 30 and 36	White blood cell count was evaluated throughout the study.

Trial Locations

Locations (15)

Petz Aladar County Teaching Hospital; 🇭🇺 Gyor, Hungary

Hospitals da Universidade de Coimbra; 🇵🇹 Coimbra, Portugal

Hopital Saint Louis - Centre d'Investigation Clinique; 🇫🇷 Paris, France

University Multiprofile Hospital for active Treatment ''Alexandrovska'' Clinic of Haematology; 🇧🇬 Sofia, Bulgaria

University Multiprofile Hospital for Active Treatment ''Dr Georgi Stranski'' - Pleven; 🇧🇬 Pleven, Bulgaria

CHU Angers Services des Maladies du Sang; 🇫🇷 Angers, Cedex 09, France

University Multiprofile Hospital for Active Treament ''Sv. Marina'' - Varna Haematology Clinic; 🇧🇬 Varna, Bulgaria

University of Debrecen Medical and Health Science Centre; 🇭🇺 Debrecen, Hungary

Pandy Kalman Hospital of Bekes County; 🇭🇺 Gyula, Hungary

Kaposi Mor Teaching Hospital; 🇭🇺 Kaposvar, Hungary

Uniwersyteckie Centrum Kliniczne Katedra i Klinika Hematologii i Transplantologii; 🇵🇱 Gdansk, Poland

Samodzielny Publiczny Szpital Kliniczny Nr 1; 🇵🇱 Lublin, Poland

Katedra i Klinika Onkologii i Chorob Wewnetrznych Akademii Medycznej; 🇵🇱 Warsaw, Poland

Klinika Hematologii Instytut Hematologii i Transfuzjologi; 🇵🇱 Warsaw, Poland

Institute for Haematology of Clinical Centre of Serbia; 🇷🇸 Belgrade, Serbia