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Milk-only Lactation Study for Patients on Eltrombopag

NCT01055600 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2015-05-13

No results posted yet for this study

Summary

This is a Phase IV study to evaluate eltrombopag concentrations in breast milk of nursing mothers taking marketed eltrombopag (PROMACTA®). Up to 10 subjects (mother-infant pairs) at as many as 10 study centers in the US will be enrolled. Nursing mothers who are registered with the PROMACTA Pregnancy Registry will be offered the option to participate in this trial if they continue to take commercial eltrombopag post-delivery and decide to breastfeed their infant. Information will be collected in a diary. Breast milk samples will be collected before and after infant feedings for a 24 hour period after eltrombopag dosing to evaluate the eltrombopag concentrations in the breast milk. Mothers will also be given the option to have a pharmacokinetic (PK) blood sample collected from the infant.

Conditions

  • Thrombocytopaenia

Interventions

DRUG

eltrombopag

Mothers are taking PROMACTA prescribed by their physician before entering this study. No drug will be administered as part of this study.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Weeks
Max Age
26 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01055600 on ClinicalTrials.gov