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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Recruitment Status : Withdrawn (Protocol opened to recruitment in Nov 2009.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
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief 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.

Condition or disease Intervention/treatment Phase
Thrombocytopaenia Drug: eltrombopag Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Phase IV Study Evaluating Eltrombopag Concentrations in Breast Milk of Nursing Mothers Taking Eltrombopag
Study Start Date : March 2013
Actual Primary Completion Date : July 2014
Estimated Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Eltrombopag
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Breast milk eltrombopag concentrations collected from nursing mothers taking eltrombopag [ Time Frame: 24 hours ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 26 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01055600


Locations
United States, North Carolina
GSK Investigational Site
Research Triangle Park, North Carolina, United States, 27709
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01055600     History of Changes
Other Study ID Numbers: 113101
First Posted: January 25, 2010    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015

Keywords provided by GlaxoSmithKline:
eltrombopag
pharmacokinetics
PROMACTA
lactation
milk-only study

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases