Milk-only Lactation Study for Patients on Eltrombopag

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01055600
First received: January 7, 2010
Last updated: August 21, 2014
Last verified: July 2014

January 7, 2010
August 21, 2014
May 2016
June 2019   (final data collection date for primary outcome measure)
Breast milk eltrombopag concentrations collected from nursing mothers taking eltrombopag [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
  • Plasma eltrombopag concentrations from infant, as data permit (optional) [ Time Frame: 1 sample within 2 days ] [ Designated as safety issue: No ]
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
Interventional
Phase 4
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Thrombocytopaenia
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.
 
Not yet recruiting
10
June 2019
June 2019   (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
Both
up to 26 Weeks
No
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com
Not Provided
 
NCT01055600
113101
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
July 2014

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