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Milk-only Lactation Study for Patients on Eltrombopag

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ClinicalTrials.gov Identifier: NCT01055600
Recruitment Status : Withdrawn (Protocol opened to recruitment in Nov 2009. No potential subjects identified in 5 years; therefore, study was terminated in Jul 2014 due to lack of feasibility)
First Posted : January 25, 2010
Last Update Posted : May 13, 2015
Information provided by (Responsible Party):

January 7, 2010
January 25, 2010
May 13, 2015
March 2013
July 2014   (Final data collection date for primary outcome measure)
Breast milk eltrombopag concentrations collected from nursing mothers taking eltrombopag [ Time Frame: 24 hours ]
Same as current
Complete list of historical versions of study NCT01055600 on ClinicalTrials.gov Archive Site
  • AEs in infant reported during the 24 hour breast milk collection period [ Time Frame: 24 hours ]
  • Plasma eltrombopag concentrations from infant, as data permit (optional) [ Time Frame: 1 sample within 2 days ]
Same as current
Not Provided
Not Provided
Milk-only Lactation Study for Patients on Eltrombopag
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.
Not Provided
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Drug: eltrombopag
Mothers are taking PROMACTA prescribed by their physician before entering this study. No drug will be administered as part of this study.
Experimental: Study
Mothers are taking PROMACTA prescribed by their physician before entering this study. No drug will be administered as part of this study.
Intervention: Drug: eltrombopag
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
July 2014
July 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 26 Weeks   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP