Clinical trial NCT00567502: Safety and Pregnancy Outcomes in Thrombocythemia Patients Exposed to XAGRID® (Anagrelide Hydrochloride) Compared to Other Treatments
Official title: A Non-Interventional, Post Authorisation Safety Study, to Continuously Monitor Safety and Pregnancy Outcomes in a Cohort of At-Risk Essential Thrombocythaemia (ET) Subjects Exposed to Xagrid Compared to Other Conventional Cytoreductive Treatments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombocythemia, Essential
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2007-12-05
Enrollment: 3647
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving cytoreductive therapy for the treatment of at-risk essential thrombocytopenia (ET).

Brief summary: This is an observational safety study being conducted in Europe comparing patients taking Xagrid to patients taking other cytoreductive treatments. The plan is to enrol at least 750 subjects taking Xagrid with up to 3000 subjects taking other cytoreductive therapies. The study will collect follow up data for 5 years for each patient enrolled that will focus on collecting data related to pre-defined events (PDEs) and Suspected Serious Adverse Reactions (SSARs).


Eligibility criteria: Inclusion Criteria:

* High risk ET patients
* Subjects who can give written informed consent.
* Subjects taking cytoreductive therapy

Exclusion Criteria:

* Contraindications listed by the product being used.
* Patient cannot be participating in another clinical trial.

Primary outcomes:
measure: Percentage of Participants With At Least One Pre-Defined Event (PDE), Deaths, Pregnancies
timeFrame: Up to 5 years
measure: Number of Participants With Suspected Serious Adverse Reaction (SSAR) Events
timeFrame: Up to 5 years
Secondary outcomes:
measure: Event Rate of Thrombohaemorrhagic Events
timeFrame: Up to 5 years
measure: Platelet Count
timeFrame: Baseline, Month 6,12,18, 24, 30, 36, 42, 48, 54, 60
measure: Duration of Exposure for Each Essential Thrombocythemia (ET) Therapy
timeFrame: Up to 5 years
measure: Cumulative Dose for Each Essential Thrombocythemia (ET) Therapy
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Limassol
country: Cyprus
facility: Clinic of Haematology
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Esbjerg
country: Denmark
facility: SUS-Esbjerg Maematologisk afdelning
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Roskilde
country: Denmark
facility: Roskilde Sygehus
city: Vejle
country: Denmark
facility: Vejle Sygehus
city: Viborg
country: Denmark
facility: Viborg Hospital
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Jyvaskyla
country: Finland
facility: Jyvaskyla Central Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Argenteuil Cedex
country: France
facility: Centre Hospitalier Victor Dupouy
city: Beauvais
country: France
facility: Centre Hospitalier de Beauvais
city: Bobigny
country: France
facility: Hopital Avicenne
city: Brest Cedex
country: France
facility: Hopital de la Cavale Blanche
city: Caen cedex
country: France
facility: CHU Clemenceau
city: Creteil
country: France
facility: Hopital Henri Mondor
city: Dijon
country: France
facility: Cabinet Medical
city: Eaubonne
country: France
facility: Hopital Simone Veil
city: Grenoble Cedex 09
country: France
facility: CHU de Grenoble Hopital Albert Michallon
city: Lens
country: France
facility: Centre Hospitalier de Lens
city: Lille cedex
country: France
facility: Hopital Saint Vincent de Paul
city: Lille cedex
country: France
facility: CHRU de Lille - Hopital Claude Huriez
city: Limoges Cedex
country: France
facility: CHU de Limoges - Hopital Universitaire Dupuytren
city: Lyon
country: France
facility: Centre Leon-Berard
city: Marseille
country: France
facility: Hopital Nord
city: Nice
country: France
facility: C.H.U. de Nice Hopital de l Archet 1
city: Paris Cedex 10
country: France
facility: Hopital Lariboisiere
city: Paris Cedex 4
country: France
facility: Hopital Hotel Dieu
city: Paris
country: France
facility: Hopital Saint-Louis
city: Paris
country: France
facility: Hopital Pitie Salpetriere
city: Pessac
country: France
facility: Hopital Haut Leveque - CHU de Bordeaux
city: Aschaffenburg
country: Germany
facility: Studienzentrum
city: Augsburg
country: Germany
facility: Praxis Dr. Heinrich, Dr. Brudler, Dr. Bangerter
city: Dresden
country: Germany
facility: Hamatologisch-Onkologische Praxis
city: Erfurt
country: Germany
facility: Praxis Dr. Weniger und Dr. Bittrich
city: Frankfurt/Main
country: Germany
facility: Onkologische Gemeinschaftspraxis
city: Hamburg
country: Germany
facility: IORC GmbH
city: Hamburg
country: Germany
city: Hornberg
country: Germany
facility: Internistische Praxis
city: Koeln
country: Germany
facility: Universitatsklinikum Koeln
city: Koln
country: Germany
facility: Praxis Schmitz and Steinmetz
city: Magdeburg
country: Germany
facility: Gemeinschaftspraxis fur Hamatologie und Internistische Onkologie
city: Moers
country: Germany
facility: Hamatologisch-Onkologische Praxis
city: Muenchen
country: Germany
facility: Praxis Dr. Schick
city: Muenster
country: Germany
facility: Hamatologisch-Onkologische Gemeinschaftspraxis
city: Munchen
country: Germany
facility: Ambulante Chemotherapie
city: Munich
country: Germany
facility: Hamato-Onkologische Schwerpunktpraxis
city: Recklinghausen
country: Germany
facility: Praxis und Tagesklinik fur Internistische Onkologie
city: Saarbruecken
country: Germany
facility: Caritasklinik St. Theresia
city: Saarbruecken
country: Germany
facility: Schwerpunktpraxis fur Hamatologie und Internistische Onkologie
city: Ulm
country: Germany
facility: Universitatsklinik Ulm
city: Weiden
country: Germany
facility: Hamatologie und Onkologie
city: Wilhelmshaven
country: Germany
facility: Praxis Dr. med. Yolanda Rodemer
city: Athens
country: Greece
facility: 401 General Army Hospital
city: Athens
country: Greece
facility: Henry Dunant Hospital
city: Athens
country: Greece
facility: General Hospital of Athens G.Gennimatas
city: Athens
country: Greece
facility: General Hospital of Athens Hippocratio
city: Athens
country: Greece
facility: General Hospital of Athens Laiko
city: Athens
country: Greece
facility: Laikon General Hospital of Athens
city: Athens
country: Greece
facility: University Hospital of Athens Attikon
city: Athens
country: Greece
facility: Hygeia Hospital
city: Athens
country: Greece
facility: 3rd Hospital of IKA
city: Athens
country: Greece
facility: General Hospital of Athens
city: Athens
country: Greece
facility: Metropolitan Hospital
city: Athens
country: Greece
facility: University Hospital of Athens ¿Attikon¿
city: Heraklion
country: Greece
facility: University Hospital of Heraklion
city: Ioannina
country: Greece
facility: University Hospital of Ioannina
city: Larissa
country: Greece
facility: University General Hospital of Larissa
city: Nicchia
country: Greece
facility: Makarios Hospital
city: Patras
country: Greece
facility: University Hospital of Patra
city: Patra
country: Greece
facility: St. Andrews General Hospital of Patra
city: Piraeus
country: Greece
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaioniki
city: Thessaloniki
country: Greece
facility: Ippokration Hospital D Clinic of Internal Medicine
city: Thessaloniki
country: Greece
facility: Papageorgiou Hospital
city: Tullamore
country: Ireland
facility: Midland Regional Hospital
city: Ancona
country: Italy
facility: Ospedale Le Torrette
city: Arezzo
country: Italy
facility: Ospedale Arezzo
city: Bari
country: Italy
facility: Ospedale Policlinico Consorziale
city: Brescia
country: Italy
facility: A.O. Spedali Civili di Brescia
city: Brindisi
country: Italy
facility: Presidio Ospedaliero Perrino
city: Catania
country: Italy
facility: Ospedale Ferrarotto
city: Civitanova Marche
country: Italy
facility: Ospedale Civile
city: Fano
country: Italy
facility: Ospedale Santa Croce
city: Florence
country: Italy
facility: Ospedale Careggi
city: Foggia
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Foggia
city: Genova
country: Italy
facility: Ospedale S. Martino
city: Genova
country: Italy
facility: Ospedale S.Martino
city: Genova
country: Italy
facility: Ospedale San Martino
city: L'Aquila
country: Italy
facility: Ospedale San salvatore
city: Mestre
country: Italy
facility: Ospedale Umberto I
city: Modena
country: Italy
facility: Policlinico
city: Monza
country: Italy
facility: Azienda ospedaliera S. Gerardo
city: Napoli
country: Italy
facility: Ospedale A.Cardarelli
city: Napoli
country: Italy
facility: Ospedale Cardarelli
city: Napoli
country: Italy
facility: Universita Federico II
city: Novara
country: Italy
facility: Ospedale Maggiore della Carita
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Parma
country: Italy
facility: Ospedale Maggiore
city: Pavia
country: Italy
facility: IRCCS Policlinico S. Matteo
city: Perugia
country: Italy
facility: Policlinico Monteluce
city: Pesaro
country: Italy
facility: Ospedale S. Salvatore
city: Piacenza
country: Italy
facility: Ospedale Civile
city: Ragusa
country: Italy
facility: Ospedale civile
city: Ravenna
country: Italy
facility: Ospedale Santa Maria delle Croci
city: Reggio Emilia
country: Italy
facility: Arcispedale S. Maria Nuova
city: Rieti
country: Italy
facility: San camillo de Lellis
city: Rionero in Vulture
country: Italy
facility: Ospedale oncologico regionale
city: Roma
country: Italy
facility: Policlinico Gemelli
city: Rome
country: Italy
facility: Ospedale Nuova Regina Margherita
city: Rome
country: Italy
facility: Ospedale Umberto I
city: Rome
country: Italy
facility: Ospedale S.Spirito
city: San Giovanni Rotondo
country: Italy
facility: Ospedale Casa Sollievo della Sofferenza
city: Terni
country: Italy
facility: Padiglione ex-oncologico Ospedale S.Maria
city: Torino
country: Italy
facility: Ospedale Luigi Gonzaga
city: Torino
country: Italy
facility: Ospedale Molinette
city: Vigevano
country: Italy
facility: Ospedale civile
city: Amsterdam
country: Netherlands
facility: VU medical Center Amsterdam
city: Fredrikstad
country: Norway
facility: Sykehuset Ostfold
city: Tromso
country: Norway
facility: Universitetssykehuset Nord-Norge Hf
city: Trondheim
country: Norway
city: Viken
country: Norway
facility: Akershus University Hospital
city: Vila Nova de Gaia
country: Portugal
facility: Servico de Hematologia
city: Barakaldo
country: Spain
facility: Hospital San Eloy
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Gerona
country: Spain
facility: Hospital Josep Trueta
city: Lugo
country: Spain
facility: Complexo Hospitalario Xeral Calde
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital U. 12 de Octubre
city: Murcia
country: Spain
facility: Hospital JM Morales Meseguer
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario Salamanca
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago
city: Valencia
country: Spain
facility: Hospital Clinico Universitario Valencia
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova
city: Falun
country: Sweden
facility: Falu Lasarett
city: Gavle
country: Sweden
facility: Medicine Clinic
city: Jonkoping
country: Sweden
facility: Lanssjukhuset Ryhov
city: Ljungby
country: Sweden
facility: Ljungby Hospital Medical Clinic
city: Malmo
country: Sweden
facility: University Hospital MAS
city: Orebro
country: Sweden
facility: University Hospital
city: Stockholm
country: Sweden
facility: Sodersjukhuset - Medicinkliniken
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Sundsvall
country: Sweden
facility: Lanssjukhuset Sundsvall - Harnosand
city: Uddevalla
country: Sweden
facility: Uddevalla Hospital
city: Uppsala
country: Sweden
facility: Akademiska Hospital Uppsala
city: Vasteras
country: Sweden
facility: Centrallasarettet - Medicinavdelningen
city: Bath
country: United Kingdom
facility: Royal United Hospital
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
city: Bristol
country: United Kingdom
facility: Avon Haematology Unit BHOC
city: Darlington
country: United Kingdom
facility: Darlington Memorial Hospital
city: Doncaster
country: United Kingdom
facility: Doncaster Royal Infirmary
city: Dudley
country: United Kingdom
facility: Georgina Oncology Unit
city: Great Yarmouth
country: United Kingdom
facility: James Paget University Hospital
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
city: London
country: United Kingdom
facility: Guy's and Thomas' NHS Foundation Trust
city: North Shields
country: United Kingdom
facility: North Tyneside General Hospital
city: Shrewsbury
country: United Kingdom
facility: Royal Shrewsbury Hospital
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Birgegard G, Besses C, Griesshammer M, Gugliotta L, Harrison CN, Hamdani M, Wu J, Achenbach H, Kiladjian JJ. Treatment of essential thrombocythemia in Europe: a prospective long-term observational study of 3649 high-risk patients in the Evaluation of Anagrelide Efficacy and Long-term Safety study. Haematologica. 2018 Jan;103(1):51-60. doi: 10.3324/haematol.2017.174672. Epub 2017 Oct 27.
citation: Gugliotta L, Besses C, Griesshammer M, Harrison C, Kiladjian JJ, Coll R, Smith J, Abhyankar B, Birgegard G. Combination therapy of hydroxycarbamide with anagrelide in patients with essential thrombocythemia in the evaluation of Xagrid(R) efficacy and long-term safety study. Haematologica. 2014 Apr;99(4):679-87. doi: 10.3324/haematol.2012.083097. Epub 2013 Dec 13.
citation: Besses C, Kiladjian JJ, Griesshammer M, Gugliotta L, Harrison C, Coll R, Smith J, Abhyankar B, Birgegard G. Cytoreductive treatment patterns for essential thrombocythemia in Europe. Analysis of 3643 patients in the EXELS study. Leuk Res. 2013 Feb;37(2):162-8. doi: 10.1016/j.leukres.2012.11.004. Epub 2012 Nov 29.
citation: Kiladjian JJ, Besses C, Griesshammer M, Gugliotta L, Harrison C, Coll R, Smith J, Birgegard G. Efficacy and safety of cytoreductive therapies in patients with essential thrombocythaemia aged >80 years: an interim analysis of the EXELS study. Clin Drug Investig. 2013 Jan;33(1):55-63. doi: 10.1007/s40261-012-0042-0.