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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
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study | Experimental | Mothers are taking PROMACTA prescribed by their physician before entering this study. No drug will be administered as part of this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eltrombopag | Drug | Mothers are taking PROMACTA prescribed by their physician before entering this study. No drug will be administered as part of this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Breast milk eltrombopag concentrations collected from nursing mothers taking eltrombopag | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Research Triangle Park | North Carolina | 27709 | United States |
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| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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| ID | Term |
|---|---|
| C520809 | eltrombopag |
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| D005247 | Feeding Behavior |
| D001519 | Behavior |