At a glance
ClinicalIndex Comparison RecordN/ACompleted· 3,647 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
An observational study for Thrombocythemia, Essential. Completed, enrolled 3,647 participants across 164 sites in 14 countries.
Detailed 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).
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsThrombocythemia, Essential
CountriesCyprus, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, United Kingdom
Collaborators--
Timeline
N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2005
First PostedDec 2007
Primary CompletionApr 2014
TodayJul 2026
First PostedDec 5, 2007
Enrollment StartMay 31, 2005
Primary CompletionApr 30, 2014
TodayJul 2, 2026
Enrollment to primary: 8.9 yearsPosted 18.6 years ago