Promacta Pregnancy Registry
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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, Thrombocytopenic, Idiopathic |
Drug: Eltrombopag |
| Study Type: | Observational [Patient Registry] |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Target Follow-Up Duration: | 5 Years |
| Official Title: | Promacta Pregnancy Registry |
- 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 2015 |
| Estimated Primary Completion Date: | January 2015 (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 |
Women exposed to eltrombopag during pregnancy, as well as infants whose mothers were exposed to eltrombopag during pregnancy.
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| Contact: US GSK Clinical Trials Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com |
| United States, North Carolina | |
| GSK Investigational Site | Recruiting |
| Research Triangle Park, North Carolina, United States, 27709 | |
| Contact: US GSK Clinical Trial Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44(0)20 8990 4466 GSKClinicalSupportHD@gsk.com | |
| 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: | January 24, 2013 |
| Health Authority: | United States: No Health Authority |
Keywords provided by GlaxoSmithKline:
|
Thrombocytopenia Pregnancy |
Additional relevant MeSH terms:
|
Purpura Purpura, Thrombocytopenic, Idiopathic Purpura, Thrombocytopenic Blood Coagulation Disorders Hematologic Diseases Hemorrhage Pathologic Processes Skin Manifestations |
Signs and Symptoms Thrombotic Microangiopathies Thrombocytopenia Blood Platelet Disorders Hemorrhagic Disorders Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013