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Promacta Pregnancy Registry


N/A
N/A
N/A
Open (Enrolling)
Both
Purpura, Thrombocytopenic, Idiopathic

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Trial Information

Promacta Pregnancy Registry


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.


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

Type of Study:

Observational [Patient Registry]

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Outcome of Pregnancy (see Detailed Description for a complete list)

Outcome Time Frame:

From exposure during pregnancy through at least the first year of infant's life

Safety Issue:

Yes

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: No Health Authority

Study ID:

113327

NCT ID:

NCT01064336

Start Date:

March 2010

Completion Date:

January 2015

Related Keywords:

  • Purpura, Thrombocytopenic, Idiopathic
  • Thrombocytopenia
  • Pregnancy
  • Purpura
  • Purpura, Thrombocytopenic, Idiopathic
  • Purpura, Thrombocytopenic

Name

Location
GSK Investigational Site Raleigh, North Carolina  27609