Thrombocythemia, Hemorrhagic Clinical Trial
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.
| Verified date | May 2021 |
| Source | Takeda |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | December 15, 2015 |
| Est. primary completion date | December 15, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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% |
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | University Multiprofile Hospital for Active Treatment ''Dr Georgi Stranski'' - Pleven | Pleven | |
| Bulgaria | University Multiprofile Hospital for active Treatment ''Alexandrovska'' Clinic of Haematology | Sofia | |
| Bulgaria | University Multiprofile Hospital for Active Treament ''Sv. Marina'' - Varna Haematology Clinic | Varna | |
| France | CHU Angers Services des Maladies du Sang | Angers | Cedex 09 |
| France | Hopital Saint Louis - Centre d'Investigation Clinique | Paris | |
| Hungary | University of Debrecen Medical and Health Science Centre | Debrecen | |
| Hungary | Petz Aladar County Teaching Hospital | Gyor | |
| Hungary | Pandy Kalman Hospital of Bekes County | Gyula | |
| Hungary | Kaposi Mor Teaching Hospital | Kaposvar | |
| Poland | 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 | |
| Portugal | Hospitals da Universidade de Coimbra | Coimbra | |
| Serbia | Institute for Haematology of Clinical Centre of Serbia | Belgrade |
| Lead Sponsor | Collaborator |
|---|---|
| Shire |
Bulgaria, France, Hungary, Poland, Portugal, Serbia,
Birgegård 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. L — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | Platelet Count at Month 6 | Platelet count was evaluated. | Month 6 | |
| Secondary | Change From Baseline in Platelet Counts at Month 3 and 36 | Platelet count was evaluated throughout the study. | Baseline and Month 3 and 36 | |
| Secondary | Percentage of Participants With Complete Response | 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. | Baseline up to Month 36 | |
| Secondary | Percentage of Participants With Partial Response | 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. | Baseline up to Month 36 | |
| Secondary | Time to Complete Response | 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). | Baseline up to Month 36 | |
| Secondary | Time to Partial Response | 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). | Baseline up to Month 36 | |
| Secondary | Number of Participants With Thrombotic and Haemorrhagic Events | 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. | From the signing of informed consent until the last study-related visit (Month 36) | |
| Secondary | Change From Baseline in White Blood Cell Count Over Time | White blood cell count was evaluated throughout the study. | Baseline and Month 6, 12, 18, 24, 30 and 36 | |
| Secondary | Change From Baseline in Red Blood Cell Count Over Time | Red blood cell count was evaluated throughout the study. | Baseline and Month 6, 12, 18, 24, 30 and 36 |