Safety and Pregnancy Outcomes in Thrombocythemia Patients Exposed to XAGRID® (Anagrelide Hydrochloride) Compared to Other Treatments
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
1 other identifier
observational
3,647
14 countries
164
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2005
Longer than P75 for all trials
164 active sites
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
Study Start
First participant enrolled
May 31, 2005
CompletedFirst Submitted
Initial submission to the registry
December 4, 2007
CompletedFirst Posted
Study publicly available on registry
December 5, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2014
CompletedResults Posted
Study results publicly available
November 17, 2015
CompletedJune 9, 2021
May 1, 2021
8.9 years
December 4, 2007
March 25, 2015
May 25, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With At Least One Pre-Defined Event (PDE), Deaths, Pregnancies
Pre-defined events (PDEs) were evaluated whenever an event occurred and was defined by a panel of independent qualified physicians, blinded to cytoreductive therapy, validated all PDEs prior to analysis (Event Validation Panel). Non-PDE death only included deaths not recorded as outcome of another PDE.
Up to 5 years
Number of Participants With Suspected Serious Adverse Reaction (SSAR) Events
SSAR: serious adverse event (SAE) that was considered related to cytoreductive therapy. SAE: any untoward medical occurrence that at any dose resulted in death, life-threatening (at the time of the event), in-patient hospitalization/prolongation of existing hospitalization (elective hospitalizations/procedures for pre-existing conditions that had not worsened were excluded), resulted in persistent or significant disability/incapacity or congenital abnormality/birth defect. Relatedness (suspected/not suspected) to XAGRID or other cytoreductive theraphy was determined by the investigator. As for SSARs, it was important to consider whether the events were related to XAGRID or other cytoreductive therapy. A participant was included in Xagrid or other treatment group based on treatment exposure, participants received Xagrid + Other was counted both in Xagrid and other treatment group.
Up to 5 years
Secondary Outcomes (4)
Event Rate of Thrombohaemorrhagic Events
Up to 5 years
Platelet Count
Baseline, Month 6,12,18, 24, 30, 36, 42, 48, 54, 60
Duration of Exposure for Each Essential Thrombocythemia (ET) Therapy
Up to 5 years
Cumulative Dose for Each Essential Thrombocythemia (ET) Therapy
Up to 5 years
Study Arms (3)
1
XAGRID® (anagrelide hydrochloride)
2
Xagrid + Other cytoreductive
3
Other cytoreductive
Eligibility Criteria
Patients receiving cytoreductive therapy for the treatment of at-risk essential thrombocytopenia (ET).
You may qualify if:
- High risk ET patients
- Subjects who can give written informed consent.
- Subjects taking cytoreductive therapy
You may not qualify if:
- Contraindications listed by the product being used.
- Patient cannot be participating in another clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (164)
Clinic of Haematology
Limassol, 3304, Cyprus
Rigshospitalet
Copenhagen, 2100, Denmark
SUS-Esbjerg Maematologisk afdelning
Esbjerg, 6700, Denmark
Herlev Hospital
Herlev, 2500, Denmark
Odense University Hospital
Odense, 5000, Denmark
Roskilde Sygehus
Roskilde, 4000, Denmark
Vejle Sygehus
Vejle, 7000, Denmark
Viborg Hospital
Viborg, 8800, Denmark
Helsinki University Hospital
Helsinki, 00029, Finland
Jyvaskyla Central Hospital
Jyväskylä, 40620, Finland
Kuopio University Hospital
Kuopio, 70211, Finland
Centre Hospitalier Victor Dupouy
Argenteuil, 95170, France
Centre Hospitalier de Beauvais
Beauvais, 60021, France
Hopital Avicenne
Bobigny, France
Hopital de la Cavale Blanche
Brest, 29609, France
CHU Clemenceau
Caen, 14033, France
Hopital Henri Mondor
Créteil, 94100, France
Cabinet Medical
Dijon, 21000, France
Hopital Simone Veil
Eaubonne, 95602, France
CHU de Grenoble Hopital Albert Michallon
Grenoble, 38043, France
Centre Hospitalier de Lens
Lens, 62307, France
Hopital Saint Vincent de Paul
Lille, 59020, France
CHRU de Lille - Hopital Claude Huriez
Lille, 59037, France
CHU de Limoges - Hopital Universitaire Dupuytren
Limoges, 87042, France
Centre Leon-Berard
Lyon, 69373, France
Hopital Nord
Marseille, 13915, France
C.H.U. de Nice Hopital de l Archet 1
Nice, 06202, France
Hopital Saint-Louis
Paris, 75010, France
Hopital Pitie Salpetriere
Paris, 75013, France
Hopital Hotel Dieu
Paris, 75181, France
Hopital Lariboisiere
Paris, 75475, France
Hopital Haut Leveque - CHU de Bordeaux
Pessac, 33604, France
Studienzentrum
Aschaffenburg, 63739, Germany
Praxis Dr. Heinrich, Dr. Brudler, Dr. Bangerter
Augsburg, 86150, Germany
Universitatsklinikum Koeln
Cologne, 50924, Germany
Praxis Schmitz and Steinmetz
Cologne, 50931, Germany
Hamatologisch-Onkologische Praxis
Dresden, 01307, Germany
Praxis Dr. Weniger und Dr. Bittrich
Erfurt, 99085, Germany
Onkologische Gemeinschaftspraxis
Frankfurt am Main, 60389, Germany
IORC GmbH
Hamburg, 22081, Germany
Unknown Facility
Hamburg, D-20095, Germany
Internistische Praxis
Hornberg, 34576, Germany
Gemeinschaftspraxis fur Hamatologie und Internistische Onkologie
Magdeburg, 39104, Germany
Hamatologisch-Onkologische Praxis
Moers, 47441, Germany
Hamato-Onkologische Schwerpunktpraxis
Munich, 80639, Germany
Praxis Dr. Schick
München, 81241, Germany
Ambulante Chemotherapie
München, 81679, Germany
Hamatologisch-Onkologische Gemeinschaftspraxis
Münster, 48149, Germany
Praxis und Tagesklinik fur Internistische Onkologie
Recklinghausen, 45657, Germany
Caritasklinik St. Theresia
Saarbrücken, 66113, Germany
Schwerpunktpraxis fur Hamatologie und Internistische Onkologie
Saarbrücken, 66113, Germany
Universitatsklinik Ulm
Ulm, 89081, Germany
Hamatologie und Onkologie
Weiden, 92637, Germany
Praxis Dr. med. Yolanda Rodemer
Wilhelmshaven, 26386, Germany
401 General Army Hospital
Athens, 11525, Greece
Henry Dunant Hospital
Athens, 11526, Greece
General Hospital of Athens G.Gennimatas
Athens, 11527, Greece
General Hospital of Athens Hippocratio
Athens, 11527, Greece
General Hospital of Athens Laiko
Athens, 11527, Greece
Laikon General Hospital of Athens
Athens, 11527, Greece
University Hospital of Athens Attikon
Athens, 12462, Greece
Hygeia Hospital
Athens, 15123, Greece
3rd Hospital of IKA
Athens, Greece
General Hospital of Athens
Athens, Greece
Metropolitan Hospital
Athens, Greece
University Hospital of Athens ¿Attikon¿
Athens, Greece
University Hospital of Heraklion
Heraklion, 71110, Greece
University Hospital of Ioannina
Ioannina, 45500, Greece
University General Hospital of Larissa
Larissa, 41110, Greece
Makarios Hospital
Nikiá, Greece
St. Andrews General Hospital of Patra
Pátrai, 26335, Greece
University Hospital of Patra
Pátrai, 26500, Greece
Unknown Facility
Piraeus, Greece
General Hospital of Thessaioniki
Thessaloniki, 54642, Greece
Ippokration Hospital D Clinic of Internal Medicine
Thessaloniki, 54642, Greece
Papageorgiou Hospital
Thessaloniki, 56403, Greece
Midland Regional Hospital
Tullamore, Ireland
Ospedale Le Torrette
Ancona, 60020, Italy
Ospedale Arezzo
Arezzo, 52100, Italy
Ospedale Policlinico Consorziale
Bari, 70124, Italy
A.O. Spedali Civili di Brescia
Brescia, 25100, Italy
Presidio Ospedaliero Perrino
Brindisi, 72100, Italy
Ospedale Ferrarotto
Catania, 95124, Italy
Ospedale Civile
Civitanova Marche, 62012, Italy
Ospedale Santa Croce
Fano, 61132, Italy
Ospedale Careggi
Florence, 50139, Italy
Azienda Ospedaliera Ospedali Riuniti Foggia
Foggia, 71100, Italy
Ospedale S. Martino
Genova, 16132, Italy
Ospedale S.Martino
Genova, 16132, Italy
Ospedale San Martino
Genova, 16132, Italy
Ospedale San salvatore
L’Aquila, 67000, Italy
Ospedale Umberto I
Mestre, 30173, Italy
Policlinico
Modena, 41100, Italy
Azienda ospedaliera S. Gerardo
Monza, 20052, Italy
Ospedale A.Cardarelli
Napoli, 80131, Italy
Ospedale Cardarelli
Napoli, 80131, Italy
Universita Federico II
Napoli, 80131, Italy
Ospedale Maggiore della Carita
Novara, 28100, Italy
Azienda Ospedaliera di Padova
Padua, 35128, Italy
Ospedale Maggiore
Parma, 43100, Italy
IRCCS Policlinico S. Matteo
Pavia, 27100, Italy
Policlinico Monteluce
Perugia, 06122, Italy
Ospedale S. Salvatore
Pesaro, 61100, Italy
Ospedale Civile
Piacenza, 29100, Italy
Ospedale civile
Ragusa, 97100, Italy
Ospedale Santa Maria delle Croci
Ravenna, 48100, Italy
Arcispedale S. Maria Nuova
Reggio Emilia, 42100, Italy
San camillo de Lellis
Rieti, 02100, Italy
Ospedale oncologico regionale
Rionero in Vulture, 85028, Italy
Policlinico Gemelli
Roma, 00168, Italy
Ospedale Nuova Regina Margherita
Rome, 00153, Italy
Ospedale Umberto I
Rome, 00161, Italy
Ospedale S.Spirito
Rome, 00193, Italy
Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, 41100, Italy
Padiglione ex-oncologico Ospedale S.Maria
Terni, 05100, Italy
Ospedale Luigi Gonzaga
Torino, 10043, Italy
Ospedale Molinette
Torino, 10126, Italy
Ospedale civile
Vigevano, 27029, Italy
VU medical Center Amsterdam
Amsterdam, 1081, Netherlands
Sykehuset Ostfold
Fredrikstad, 1603, Norway
Universitetssykehuset Nord-Norge Hf
Tromsø, 1919, Norway
Unknown Facility
Trondheim, 7006, Norway
Akershus University Hospital
Viken, 1474, Norway
Servico de Hematologia
Vila Nova de Gaia, 4430, Portugal
Hospital San Eloy
Barakaldo, 48902, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Germans Trias i Pujol
Barcelona, 08916, Spain
Hospital Josep Trueta
Girona, 17007, Spain
Complexo Hospitalario Xeral Calde
Lugo, 27004, Spain
Hospital Universitario de la Princesa
Madrid, 28006, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Clinico San Carlos
Madrid, 28040, Spain
Hospital U. 12 de Octubre
Madrid, 28041, Spain
Hospital JM Morales Meseguer
Murcia, 30008, Spain
Hospital Clinico Universitario Salamanca
Salamanca, 37007, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, 38320, Spain
Hospital Clinico Universitario de Santiago
Santiago de Compostela, 15706, Spain
Hospital Clinico Universitario Valencia
Valencia, 46010, Spain
Consorcio Hospital General Universitario de Valencia
Valencia, 46014, Spain
Hospital Arnau de Vilanova
Valencia, 46015, Spain
Falu Lasarett
Falun, 79182, Sweden
Medicine Clinic
Gävle, SE 80187, Sweden
Lanssjukhuset Ryhov
Jönköping, 55185, Sweden
Ljungby Hospital Medical Clinic
Ljungby, 341 82, Sweden
University Hospital MAS
Malmo, 20502, Sweden
University Hospital
Örebro, 70185, Sweden
Sodersjukhuset - Medicinkliniken
Stockholm, 11883, Sweden
Karolinska University Hospital
Stockholm, 14186, Sweden
Lanssjukhuset Sundsvall - Harnosand
Sundsvall, 85188, Sweden
Uddevalla Hospital
Uddevalla, 45180, Sweden
Akademiska Hospital Uppsala
Uppsala, 75185, Sweden
Centrallasarettet - Medicinavdelningen
Västerås, 72189, Sweden
Royal United Hospital
Bath, BA1 3NG, United Kingdom
Belfast City Hospital
Belfast, BT9 7AB, United Kingdom
Birmingham Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
Avon Haematology Unit BHOC
Bristol, BS9 1BD, United Kingdom
Darlington Memorial Hospital
Darlington, DL3 6HX, United Kingdom
Doncaster Royal Infirmary
Doncaster, DN2 5LT, United Kingdom
Georgina Oncology Unit
Dudley, DYI 2HQ, United Kingdom
James Paget University Hospital
Great Yarmouth, NR31 6LA, United Kingdom
Hull Royal Infirmary
Hull, HU3 2JZ, United Kingdom
Guy's and Thomas' NHS Foundation Trust
London, SE17EH, United Kingdom
North Tyneside General Hospital
North Shields, NE298NH, United Kingdom
Royal Shrewsbury Hospital
Shrewsbury, SY3 8QR, United Kingdom
Related Publications (4)
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.
PMID: 29079600DERIVEDGugliotta 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.
PMID: 24334294DERIVEDBesses 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.
PMID: 23199894DERIVEDKiladjian 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.
PMID: 23184668DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Results for other adverse events (excluding SAEs) was reported under OM 1 due to limitation in basic result's format, as SAEs and non-SAEs were not planned to be reported separately.
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2007
First Posted
December 5, 2007
Study Start
May 31, 2005
Primary Completion
April 30, 2014
Study Completion
April 30, 2014
Last Updated
June 9, 2021
Results First Posted
November 17, 2015
Record last verified: 2021-05