Safety and Pregnancy Outcomes in Thrombocythemia Patients Exposed to XAGRID® (Anagrelide Hydrochloride) Compared to Other Treatments

May 25, 2021 updated by: Shire

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

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

3647

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cyprus
      • Limassol, Cyprus, 3304
        • Clinic of Haematology
  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
      • Esbjerg, Denmark, 6700
        • SUS-Esbjerg Maematologisk afdelning
      • Herlev, Denmark, 2500
        • Herlev Hospital
      • Odense, Denmark, 5000
        • Odense University Hospital
      • Roskilde, Denmark, 4000
        • Roskilde Sygehus
      • Vejle, Denmark, 7000
        • Vejle Sygehus
      • Viborg, Denmark, 8800
        • Viborg Hospital
  • Finland
      • Helsinki, Finland, 00029
        • Helsinki University Hospital
      • Jyvaskyla, Finland, 40620
        • Jyväskylä Central Hospital
      • Kuopio, Finland, 70211
        • Kuopio University Hospital
  • France
      • Argenteuil Cedex, France, 95170
        • Centre Hospitalier Victor Dupouy
      • Beauvais, France, 60021
        • Centre Hospitalier de Beauvais
      • Bobigny, France
        • Hôpital Avicenne
      • Brest Cedex, France, 29609
        • Hôpital de la cavale Blanche
      • Caen cedex, France, 14033
        • CHU Clemenceau
      • Creteil, France, 94100
        • Hôpital Henri Mondor
      • Dijon, France, 21000
        • Cabinet Médical
      • Eaubonne, France, 95602
        • Hôpital Simone Veil
      • Grenoble Cedex 09, France, 38043
        • CHU de Grenoble Hopital Albert Michallon
      • Lens, France, 62307
        • Centre Hospitalier de LENS
      • Lille cedex, France, 59037
        • CHRU de Lille - Hopital Claude Huriez
      • Lille cedex, France, 59020
        • Hôpital Saint Vincent de Paul
      • Limoges Cedex, France, 87042
        • CHU de Limoges - Hopital Universitaire Dupuytren
      • Lyon, France, 69373
        • Centre Leon-Berard
      • Marseille, France, 13915
        • Hopital Nord
      • Nice, France, 06202
        • C.H.U. de Nice Hopital de l Archet 1
      • Paris, France, 75013
        • Hôpital Pitié Salpêtrière
      • Paris, France, 75010
        • Hôpital Saint-Louis
      • Paris Cedex 10, France, 75475
        • Hôpital Lariboisiere
      • Paris Cedex 4, France, 75181
        • Hôpital Hotel Dieu
      • Pessac, France, 33604
        • Hopital Haut Leveque - CHU de Bordeaux
  • Germany
      • Aschaffenburg, Germany, 63739
        • Studienzentrum
      • Augsburg, Germany, 86150
        • Praxis Dr. Heinrich, Dr. Brudler, Dr. Bangerter
      • Dresden, Germany, 01307
        • Hämatologisch-Onkologische Praxis
      • Erfurt, Germany, 99085
        • Praxis Dr. Weniger und Dr. Bittrich
      • Frankfurt/Main, Germany, 60389
        • Onkologische Gemeinschaftspraxis
      • Hamburg, Germany, 22081
        • IORC GmbH
      • Hamburg, Germany, D-20095
      • Hornberg, Germany, 34576
        • Internistische Praxis
      • Koeln, Germany, 50924
        • Universitätsklinikum Koeln
      • Koln, Germany, 50931
        • Praxis Schmitz and Steinmetz
      • Magdeburg, Germany, 39104
        • Gemeinschaftspraxis für Hämatologie und internistische Onkologie
      • Moers, Germany, 47441
        • Hämatologisch-Onkologische Praxis
      • Muenchen, Germany, 81241
        • Praxis Dr. Schick
      • Muenster, Germany, 48149
        • Hämatologisch-onkologische Gemeinschaftspraxis
      • Munchen, Germany, 81679
        • Ambulante Chemotherapie
      • Munich, Germany, 80639
        • Hämato-Onkologische Schwerpunktpraxis
      • Recklinghausen, Germany, 45657
        • Praxis und Tagesklinik fur Internistische Onkologie
      • Saarbruecken, Germany, 66113
        • Caritasklinik St. Theresia
      • Saarbruecken, Germany, 66113
        • Schwerpunktpraxis fur Hamatologie und Internistische Onkologie
      • Ulm, Germany, 89081
        • Universitätsklinik Ulm
      • Weiden, Germany, 92637
        • Hamatologie und Onkologie
      • Wilhelmshaven, Germany, 26386
        • Praxis Dr. med. Yolanda Rodemer
  • Greece
      • Athens, Greece, 11527
        • General Hospital of Athens Laiko
      • Athens, Greece, 15123
        • Hygeia Hospital
      • Athens, Greece, 11526
        • Henry Dunant Hospital
      • Athens, Greece
        • General Hospital of Athens
      • Athens, Greece, 11525
        • 401 General Army Hospital
      • Athens, Greece, 11527
        • General Hospital of Athens G.Gennimatas
      • Athens, Greece, 11527
        • General Hospital of Athens Hippocratio
      • Athens, Greece, 11527
        • Laikon General Hospital of Athens
      • Athens, Greece, 12462
        • University Hospital of Athens ATTIKON
      • Athens, Greece
        • 3rd Hospital of IKA
      • Athens, Greece
        • Metropolitan Hospital
      • Athens, Greece
        • University Hospital of Athens ¿Attikon¿
      • Heraklion, Greece, 71110
        • University Hospital of Heraklion
      • Ioannina, Greece, 45500
        • University Hospital of Ioannina
      • Larissa, Greece, 41110
        • University General Hospital of Larissa
      • Nicchia, Greece
        • Makarios Hospital
      • Patra, Greece, 26335
        • St. Andrews General Hospital of Patra
      • Patras, Greece, 26500
        • University Hospital of Patra
      • Piraeus, Greece
      • Thessaloniki, Greece, 54642
        • General Hospital of Thessaioniki
      • Thessaloniki, Greece, 54642
        • Ippokration Hospital D Clinic of Internal Medicine
      • Thessaloniki, Greece, 56403
        • Papageorgiou Hospital
  • Ireland
      • Tullamore, Ireland
        • Midland Regional Hospital
  • Italy
      • Ancona, Italy, 60020
        • Ospedale le Torrette
      • Arezzo, Italy, 52100
        • Ospedale Arezzo
      • Bari, Italy, 70124
        • Ospedale Policlinico Consorziale
      • Brescia, Italy, 25100
        • A.O. Spedali Civili di Brescia
      • Brindisi, Italy, 72100
        • Presidio Ospedaliero Perrino
      • Catania, Italy, 95124
        • Ospedale Ferrarotto
      • Civitanova Marche, Italy, 62012
        • Ospedale Civile
      • Fano, Italy, 61132
        • Ospedale Santa Croce
      • Florence, Italy, 50139
        • Ospedale Careggi
      • Foggia, Italy, 71100
        • Azienda Ospedaliera Ospedali Riuniti Foggia
      • Genova, Italy, 16132
        • Ospedale San Martino
      • Genova, Italy, 16132
        • Ospedale S. Martino
      • Genova, Italy, 16132
        • Ospedale S.Martino
      • L'Aquila, Italy, 67000
        • Ospedale San Salvatore
      • Mestre, Italy, 30173
        • Ospedale Umberto I
      • Modena, Italy, 41100
        • Policlinico
      • Monza, Italy, 20052
        • Azienda Ospedaliera S. Gerardo
      • Napoli, Italy, 80131
        • Università Federico II
      • Napoli, Italy, 80131
        • Ospedale A.Cardarelli
      • Napoli, Italy, 80131
        • Ospedale Cardarelli
      • Novara, Italy, 28100
        • Ospedale Maggiore della Carità
      • Padova, Italy, 35128
        • Azienda Ospedaliera Di Padova
      • Parma, Italy, 43100
        • Ospedale Maggiore
      • Pavia, Italy, 27100
        • IRCCS Policlinico S. Matteo
      • Perugia, Italy, 06122
        • Policlinico Monteluce
      • Pesaro, Italy, 61100
        • Ospedale S. Salvatore
      • Piacenza, Italy, 29100
        • Ospedale Civile
      • Ragusa, Italy, 97100
        • Ospedale Civile
      • Ravenna, Italy, 48100
        • Ospedale Santa Maria Delle Croci
      • Reggio Emilia, Italy, 42100
        • Arcispedale S. Maria Nuova
      • Rieti, Italy, 02100
        • San camillo de Lellis
      • Rionero in Vulture, Italy, 85028
        • Ospedale Oncologico Regionale
      • Roma, Italy, 00168
        • Policlinico Gemelli
      • Rome, Italy, 00153
        • Ospedale Nuova Regina Margherita
      • Rome, Italy, 00161
        • Ospedale Umberto I
      • Rome, Italy, 00193
        • Ospedale S.Spirito
      • San Giovanni Rotondo, Italy, 41100
        • Ospedale Casa Sollievo della Sofferenza
      • Terni, Italy, 05100
        • Padiglione ex-oncologico Ospedale S.Maria
      • Torino, Italy, 10126
        • Ospedale Molinette
      • Torino, Italy, 10043
        • Ospedale Luigi Gonzaga
      • Vigevano, Italy, 27029
        • Ospedale Civile
  • Netherlands
      • Amsterdam, Netherlands, 1081
        • VU medical center Amsterdam
  • Norway
      • Fredrikstad, Norway, 1603
        • Sykehuset Ostfold
      • Tromso, Norway, 1919
        • Universitetssykehuset Nord-Norge HF
      • Trondheim, Norway, 7006
      • Viken, Norway, 1474
        • Akershus University Hospital
  • Portugal
      • Vila Nova de Gaia, Portugal, 4430
        • Serviço de Hematologia
  • Spain
      • Barakaldo, Spain, 48902
        • Hospital San Eloy
      • Barcelona, Spain, 08003
        • Hospital Del Mar
      • Barcelona, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Gerona, Spain, 17007
        • Hospital Josep Trueta
      • Lugo, Spain, 27004
        • Complexo Hospitalario Xeral Calde
      • Madrid, Spain, 28034
        • Hospital Universitario Ramón y Cajal
      • Madrid, Spain, 28040
        • Hospital Clínico San Carlos
      • Madrid, Spain, 28006
        • Hospital Universitario de La Princesa
      • Madrid, Spain, 28041
        • Hospital U. 12 de Octubre
      • Murcia, Spain, 30008
        • Hospital JM Morales Meseguer
      • Salamanca, Spain, 37007
        • Hospital Clinico Universitario Salamanca
      • Santa Cruz de Tenerife, Spain, 38320
        • Hospital Universitario de Canarias
      • Santiago de Compostela, Spain, 15706
        • Hospital Clínico Universitario de Santiago
      • Valencia, Spain, 46015
        • Hospital Arnau de Vilanova
      • Valencia, Spain, 46014
        • Consorcio Hospital General Universitario de Valencia
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario Valencia
  • Sweden
      • Falun, Sweden, 79182
        • Falu Lasarett
      • Gavle, Sweden, SE 80187
        • Medicine Clinic
      • Jonkoping, Sweden, 55185
        • Länssjukhuset Ryhov
      • Ljungby, Sweden, 341 82
        • Ljungby Hospital Medical Clinic
      • Malmo, Sweden, 20502
        • University Hospital MAS
      • Orebro, Sweden, 70185
        • University Hospital
      • Stockholm, Sweden, 14186
        • Karolinska University Hospital
      • Stockholm, Sweden, 11883
        • Sodersjukhuset - Medicinkliniken
      • Sundsvall, Sweden, 85188
        • Lanssjukhuset Sundsvall - Harnosand
      • Uddevalla, Sweden, 45180
        • Uddevalla Hospital
      • Uppsala, Sweden, 75185
        • Akademiska Hospital Uppsala
      • Vasteras, Sweden, 72189
        • Centrallasarettet - Medicinavdelningen
  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
        • Royal United Hospital
      • Belfast, United Kingdom, BT9 7AB
        • Belfast City Hospital
      • Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
      • Bristol, United Kingdom, BS9 1BD
        • Avon Haematology Unit BHOC
      • Darlington, United Kingdom, DL3 6HX
        • Darlington Memorial Hospital
      • Doncaster, United Kingdom, DN2 5LT
        • Doncaster Royal Infirmary
      • Dudley, United Kingdom, DYI 2HQ
        • Georgina Oncology Unit
      • Great Yarmouth, United Kingdom, NR31 6LA
        • James Paget University Hospital
      • Hull, United Kingdom, HU3 2JZ
        • Hull Royal Infirmary
      • London, United Kingdom, SE17EH
        • Guy's and Thomas' NHS Foundation Trust
      • North Shields, United Kingdom, NE298NH
        • North Tyneside General Hospital
      • Shrewsbury, United Kingdom, SY3 8QR
        • Royal Shrewsbury Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients receiving cytoreductive therapy for the treatment of at-risk essential thrombocytopenia (ET).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1
XAGRID® (anagrelide hydrochloride)
2
Xagrid + Other cytoreductive
3
Other cytoreductive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With At Least One Pre-Defined Event (PDE), Deaths, Pregnancies
Time Frame: Up to 5 years
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
Time Frame: Up to 5 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event Rate of Thrombohaemorrhagic Events
Time Frame: Up to 5 years
Event Rate of Thrombohaemorrhagic Events was calculated by dividing number of participants with events by total patient-year exposure. The reporting unit is per 100 participant-years of treatment exposure. Thrombohaemorrhagic Events is a composite endpoint of the PDEs myocardial infarction, angina, stroke, transient ischaemic attack, venous thromboembolic events, intermittent claudication/digital ischaemia, and major haemorrhagic events.
Up to 5 years
Platelet Count
Time Frame: Baseline, Month 6,12,18, 24, 30, 36, 42, 48, 54, 60
Baseline, Month 6,12,18, 24, 30, 36, 42, 48, 54, 60
Duration of Exposure for Each Essential Thrombocythemia (ET) Therapy
Time Frame: Up to 5 years
Total duration for each participant = sum of [stop date - start date + 1] across all periods of time where the specific treatment was taken during the study, where start date = registration/consent date for treatments started before registration/consent date and/or stop date withdrawal/final date for treatments ongoing at the time of withdrawal/end of study. Where a participant has multiple records of the same therapy on the same day, the therapy is counted once for that day.
Up to 5 years
Cumulative Dose for Each Essential Thrombocythemia (ET) Therapy
Time Frame: Up to 5 years
Since the study is observational nature, interpreting the table is difficult due to inconsistencies in reporting the units of the dose.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2005

Primary Completion (Actual)

April 30, 2014

Study Completion (Actual)

April 30, 2014

Study Registration Dates

First Submitted

December 4, 2007

First Submitted That Met QC Criteria

December 4, 2007

First Posted (Estimate)

December 5, 2007

Study Record Updates

Last Update Posted (Actual)

June 9, 2021

Last Update Submitted That Met QC Criteria

May 25, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPD422-401

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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