Promacta Pregnancy Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01064336
First received: February 4, 2010
Last updated: September 15, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Purpura, Thrombocytopaenic, Idiopathic
Drug: Eltrombopag

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Years
Official Title: Promacta Pregnancy Registry

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Outcome of Pregnancy (see Detailed Description for a complete list) [ Time Frame: From exposure during pregnancy through at least the first year of infant's life ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1
Study Start Date: March 2010
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pregnant women on eltrombopag
Any women with eltrombopag exposure during pregnancy that is reported prior to or after knowledge of the pregnancy outcome, substantiated by health care provider, and meeting the enrollment 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.)
Drug: Eltrombopag
Eltrombopag is an orally bioavailable, small molecule thrombopoietin receptor (TPO-R) agonist for the treatment of idiopathic thrombocytopenic purpura
Infants
Infants through the first year of life whose mothers were exposed to eltrombopag during pregnancy.
Drug: Eltrombopag
Eltrombopag is an orally bioavailable, small molecule thrombopoietin receptor (TPO-R) agonist for the treatment of idiopathic thrombocytopenic purpura

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01064336

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
United States, North Carolina
GSK Investigational Site Recruiting
Research Triangle Park, North Carolina, United States, 27709
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01064336     History of Changes
Other Study ID Numbers: 113327, WE4032
Study First Received: February 4, 2010
Last Updated: September 15, 2014
Health Authority: United States: No Health Authority

Keywords provided by GlaxoSmithKline:
Thrombocytopenia
Pregnancy

Additional relevant MeSH terms:
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Purpura
Blood Coagulation Disorders
Hematologic Diseases
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Hemorrhagic Disorders
Autoimmune Diseases

ClinicalTrials.gov processed this record on October 19, 2014