Milk-only Lactation Study for Patients on Eltrombopag

NCT01055600 | Withdrawn Phase 4

• 1 other identifier: 113101
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Thrombocytopaenia

Keywords

eltrombopag; pharmacokinetics; PROMACTA; lactation; milk-only study

Outcome Measures

Primary Outcomes (1)

• Breast milk eltrombopag concentrations collected from nursing mothers taking eltrombopag

  24 hours

Secondary Outcomes (2)

• AEs in infant reported during the 24 hour breast milk collection period

  24 hours

• Plasma eltrombopag concentrations from infant, as data permit (optional)

  1 sample within 2 days

Study Arms (1)

Study

EXPERIMENTAL

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

Drug: eltrombopag

Interventions

eltrombopag DRUG

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

Study

Eligibility Criteria

• Age: 4 Weeks - 26 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Research Triangle Park, North Carolina, 27709, United States

Location

MeSH Terms

Conditions

Thrombocytopenia; Breast Feeding

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Feeding Behavior; Behavior

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2010
• First Posted: January 25, 2010
• Study Start: March 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: May 13, 2015

Record last verified: 2015-05

Locations

US (1)