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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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
        • Hopital 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 Medical
      • 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
        • Hopital Saint Vincent de Paul
      • Limoges Cedex, France, 87042
        • CHU de Limoges - Hôpital 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
        • Hopital Pitie Salpetriere
      • Paris, France, 75010
        • Hôpital Saint-Louis
      • Paris Cedex 10, France, 75475
        • Hopital Lariboisiere
      • Paris Cedex 4, France, 75181
        • Hôpital Hôtel 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
        • Universitatsklinikum 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 Clinico 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 Clinico Universitario de Santiago
      • Valencia, Spain, 46015
        • Hospital Arnau de Vilanova
      • Valencia, Spain, 46014
        • Consorcio Hospital General Universitario de Valencia
      • Valencia, Spain, 46010
        • Hospital Clínico 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
1
XAGRID® (anagrelide hydrochloride)
2
Xagrid + Other cytoreductive
3
Other cytoreductive

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 31, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2007

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 9, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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