Promacta Pregnancy Registry
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Purpura, Thrombocytopenic, Idiopathic
Intervention: Eltrombopag (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Overall contact:
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
Summary
Since Idiopathic Thrombocytopenic Purpura (ITP) affects women who are of reproductive
capacity and taking into account the lack of data concerning Eltrombopag (Promacta) use
during pregnancy, the Eltrombopag (Promacta) Registry will be an essential component of the
ongoing risk management for Eltrombopag (Promacta). The Registry will detect and record the
events (live births, spontaneous abortions, stillbirths, elective terminations, therapeutic
terminations, any serious pregnancy outcome, major and minor congenital anomalies, outcomes
including preterm, small for gestation age, or intrauterine growth restriction adverse
adverse effects on the following: immune system development, platelet number and function,
neoplasm formation, bone marrow reticulin formation, thrombotic events) in the mother and/or
the neonate/infant. The adverse events in the infant will be assessed through at least the
first year of life. The Pregnancy Registry will compare the pregnancy and fetal outcomes of
women exposed to eltrombopag Tablets during pregnancy to an unexposed control population.
This study will be a prospective observational, exposure follow-up study.
Clinical Details
Official title: Promacta Pregnancy Registry
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Outcome of Pregnancy (see Detailed Description for a complete list)
Detailed description:
The outcomes of pregnancy are: live births, spontaneous abortions, stillbirths, elective
terminations, therapeutic terminations, any serious pregnancy outcome, major and minor
congenital anomalies, outcomes including preterm, small for gestation age, or intrauterine
growth restriction adverse effects on the following: immune system development, platelet
number and function, neoplasm formation, bone marrow reticulin formation, thrombotic events
in the mother and/or the neonate/infant.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Documentation that Eltrombopag is being taken during pregnancy. Timing of the prenatal
exposure to Eltrombopag (i. e. best estimation of which trimester in pregnancy that there
was exposure to Eltrombopag for stratification and reporting purposes). Sufficient
information to determine whether the pregnancy is being prospectively or retrospectively
registered. Whether the outcome of pregnancy was known at the time of the report. Source
of the report (i. e. health care professional, patient). Full provider contact information
to allow for follow-up (name, address, etc.)
Exclusion Criteria: None
Locations and Contacts
US GSK Clinical Trials Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
GSK Investigational Site, Research Triangle Park, North Carolina 27709, United States; Recruiting
US GSK Clinical Trial Call Center, Phone: 877-379-3718, Email: GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center, Phone: +44(0)20 8990 4466, Email: GSKClinicalSupportHD@gsk.com
Additional Information
Starting date: March 2010
Last updated: January 24, 2013
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