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
  Purpose

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 Intervention Phase
Thrombocytopaenia
Drug: eltrombopag
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase IV Study Evaluating Eltrombopag Concentrations in Breast Milk of Nursing Mothers Taking Eltrombopag

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Breast milk eltrombopag concentrations collected from nursing mothers taking eltrombopag [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10
Study Start Date: May 2016
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   up to 26 Weeks
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055600

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01055600     History of Changes
Other Study ID Numbers: 113101
Study First Received: January 7, 2010
Last Updated: August 21, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on October 02, 2014