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


Phase 4
N/A
26 Weeks
Open (Enrolling by invite only)
Both
Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Breast milk eltrombopag concentrations collected from nursing mothers taking eltrombopag

Outcome Time Frame:

24 hours

Safety Issue:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

113101

NCT ID:

NCT01055600

Start Date:

April 2013

Completion Date:

June 2019

Related Keywords:

  • Cancer
  • milk-only study
  • PROMACTA
  • eltrombopag
  • pharmacokinetics
  • lactation

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