Trials / Completed
CompletedNCT00567502
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 3,647 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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).
Conditions
Timeline
- Start date
- 2005-05-31
- Primary completion
- 2014-04-30
- Completion
- 2014-04-30
- First posted
- 2007-12-05
- Last updated
- 2021-06-09
- Results posted
- 2015-11-17
Locations
164 sites across 14 countries: Cyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, United Kingdom
Source: ClinicalTrials.gov record NCT00567502. Inclusion in this directory is not an endorsement.