Safety and Pregnancy Outcomes in Thrombocythemia Patients Exposed to Xagrid Compared to Other Treatments

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Shire Development LLC

ClinicalTrials.gov Identifier:

NCT00567502

First received: December 4, 2007

Last updated: December 12, 2012

Last verified: December 2012

History of Changes

Purpose

This is an observational safety study being conducted in Europe comparing patients taking Xagrid to patients taking other cytoreductive treatments. The plan is to enroll at least 1000 subjects taking Xagrid with up to 3000 subjects taking other cytoreductive therapies. The study will collect data in two phases: the initial 5 year phase will focus on collecting data related to pre-defined events and Suspected Serious Adverse Reactions (SSARs); the second 5 year period will be to follow up on pre-defined events and SSARs.

Condition
Thrombocythemia, Essential

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
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

Resource links provided by NLM:

Genetics Home Reference related topics: essential thrombocythemia

Drug Information available for: Anagrelide hydrochloride Anagrelide

U.S. FDA Resources

Further study details as provided by Shire Development LLC:

Estimated Enrollment:	4000
Study Start Date:	May 2005
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Xagrid
2 Xagrid + Other cytoreductive
3 Other cytoreductive

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567502

Show 165 Study Locations

Sponsors and Collaborators

Shire Development LLC

Investigators

Principal Investigator:

Gunnar Birgegard, MD

University Hospital, Uppsala, Sweden

More Information

No publications provided by Shire Development LLC

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Besses C, Kiladjian JJ, Griesshammer M, Gugliotta L, Harrison C, Coll R, Smith J, Abhyankar B, Birgegård 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.

Kiladjian JJ, Besses C, Griesshammer M, Gugliotta L, Harrison C, Coll R, Smith J, Birgegård 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.

Responsible Party:	Shire Development LLC
ClinicalTrials.gov Identifier:	NCT00567502 History of Changes
Other Study ID Numbers:	SPD422-401
Study First Received:	December 4, 2007
Last Updated:	December 12, 2012
Health Authority:	United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:

Thrombocythemia, Essential
Thrombocytosis
Blood Coagulation Disorders
Hematologic Diseases

Blood Platelet Disorders
Myeloproliferative Disorders
Bone Marrow Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on May 19, 2013

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