Promacta Pregnancy Registry
22 juli 2016 uppdaterad av: GlaxoSmithKline
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
1
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Women exposed to eltrombopag during pregnancy, as well as infants whose mothers were exposed to eltrombopag during pregnancy.
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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.)
|
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.
|
Eltrombopag is an orally bioavailable, small molecule thrombopoietin receptor (TPO-R) agonist for the treatment of idiopathic thrombocytopenic purpura
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Outcome of Pregnancy (see Detailed Description for a complete list)
Tidsram: From exposure during pregnancy through at least the first year of infant's life
|
From exposure during pregnancy through at least the first year of infant's life
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2010
Primärt slutförande (Faktisk)
1 juli 2014
Avslutad studie (Faktisk)
1 juli 2014
Studieregistreringsdatum
Först inskickad
4 februari 2010
Först inskickad som uppfyllde QC-kriterierna
4 februari 2010
Första postat (Uppskatta)
8 februari 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
25 juli 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 juli 2016
Senast verifierad
1 juli 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Patologiska processer
- Immunsystemets sjukdomar
- Autoimmuna sjukdomar
- Hematologiska sjukdomar
- Blödning
- Hemorragiska störningar
- Blodkoagulationsstörningar
- Hudmanifestationer
- Trombocytopeni
- Blodplättssjukdomar
- Trombotiska mikroangiopatier
- Purpura
- Purpura, trombocytopenisk
- Purpura, Trombocytopenisk, Idiopatisk
Andra studie-ID-nummer
- 113327
- WE4032 (Annan identifierare: GSK)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .