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
ClinicalTrials.gov Identifier:
NCT00567502
First received: December 4, 2007
Last updated: February 6, 2014
Last verified: February 2014
  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 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).


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:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Monitor Safety and pregnancy Outcomes [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Platelet Reduction [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Thrombohemorrhagic Events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Drug Dose [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Duration of Drug Exposure [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 3650
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 164 Study Locations
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Gunnar Birgegard, MD University Hospital, Uppsala, Sweden
  More Information

No publications provided by Shire

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00567502     History of Changes
Other Study ID Numbers: SPD422-401
Study First Received: December 4, 2007
Last Updated: February 6, 2014
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 April 17, 2014