Last updated: 11/03/2018 14:14:13
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
Milk-only lactation study for patients on eltrombopag
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: A Phase IV study evaluating eltrombopag concentrations in breast milk of nursing mothers taking eltrombopag
Trial description: 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.
Primary purpose:
Other
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Breast milk eltrombopag concentrations collected from nursing mothers taking eltrombopag
Timeframe: 24 hours
Secondary outcomes:
AEs in infant reported during the 24 hour breast milk collection period
Timeframe: 24 hours
Plasma eltrombopag concentrations from infant, as data permit (optional)
Timeframe: 1 sample within 2 days
Interventions:
Drug: eltrombopag
Enrollment:
0
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Thrombocytopaenia
Product
eltrombopag
Collaborators
GSK
Study date(s)
March 2013 to July 2014
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
4 - 26 weeks
Accepts healthy volunteers
No
- 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.
- 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).
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Research Triangle Park, North Carolina, United States, 27709
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
No longer a GSK study
Actual primary completion date
Not applicable
Actual study completion date
2014-21-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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