Milk-only Lactation Study for Patients on Eltrombopag

Thrombocytopaenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01055600
• Other study ID #: 113101
• Status: Withdrawn
• Phase: Phase 4
• First received: January 7, 2010
• Last updated: May 11, 2015
• Start date: March 2013
• Est. completion date: July 2014

Study information

• Verified date: May 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 26 Weeks

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Thrombocytopaenia
• Thrombocytopenia
• Thrombocytosis

Intervention

Drug:
• eltrombopag
Mothers are taking PROMACTA prescribed by their physician before entering this study. No drug will be administered as part of this study.

Locations

Country	Name	City	State
United States	GSK Investigational Site	Research Triangle Park	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breast milk eltrombopag concentrations collected from nursing mothers taking eltrombopag		24 hours	No
Secondary	AEs in infant reported during the 24 hour breast milk collection period		24 hours	Yes
Secondary	Plasma eltrombopag concentrations from infant, as data permit (optional)		1 sample within 2 days	No