Milk-only Lactation Study for Patients on Eltrombopag

May 11, 2015 updated by: GlaxoSmithKline

A Phase IV Study Evaluating Eltrombopag Concentrations in Breast Milk of Nursing Mothers Taking Eltrombopag

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Research Triangle Park, North Carolina, United States, 27709
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 5 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mother is registered with the PROMACTA Pregnancy Registry and meets all the enrollment criteria defined in the PROMACTA Pregnancy Registry study (113327).
  • Mother is continuing to take eltrombopag.
  • Mother has received 7 consecutive eltrombopag doses prior to the milk sample collection.
  • Infant is 4 weeks to 26 weeks of age at the time of milk sampling.
  • Exclusively breastfeeding mother-infant pair; either via breast or with expressed milk from the mother.
  • Mother is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Exclusion Criteria:

  • Infant was born with complications that could impact ability to participate in this study.
  • Breastfeeding is not well established in the mother-infant pair (e.g., poor latching of the infant or low milk supply).
  • Infants who are supplemented with formula or are consuming solid foods.
  • Unwillingness or inability of mother to follow the procedures outlined in the protocol.
  • Mother is mentally or legally incapacitated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Study
Mothers are taking PROMACTA prescribed by their physician before entering this study. No drug will be administered as part of this study.
Drug: eltrombopag
Mothers are taking PROMACTA prescribed by their physician before entering this study. No drug will be administered as part of this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Breast milk eltrombopag concentrations collected from nursing mothers taking eltrombopag
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
AEs in infant reported during the 24 hour breast milk collection period
Time Frame: 24 hours
24 hours
Plasma eltrombopag concentrations from infant, as data permit (optional)
Time Frame: 1 sample within 2 days
1 sample within 2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

January 7, 2010

First Submitted That Met QC Criteria

January 21, 2010

First Posted (Estimate)

January 25, 2010

Study Record Updates

Last Update Posted (Estimate)

May 13, 2015

Last Update Submitted That Met QC Criteria

May 11, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 113101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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