Clinical trial NCT01064336: Promacta Pregnancy Registry
Official title: Promacta Pregnancy Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Purpura, Thrombocytopaenic, Idiopathic
Keywords: Thrombocytopenia
Pregnancy
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-02-08
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women exposed to eltrombopag during pregnancy, as well as infants whose mothers were exposed to eltrombopag during pregnancy.

Brief 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.

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 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

Primary outcomes:
measure: Outcome of Pregnancy (see Detailed Description for a complete list)
timeFrame: From exposure during pregnancy through at least the first year of infant's life
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: