ThrombocytopaeniaPhase 4NCT01055600
Milk-only Lactation Study for Patients on Eltrombopag
A Phase 4 study testing eltrombopag in people with Thrombocytopaenia, run by GlaxoSmithKline at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 4 to 26 weeks
- Conditions the study is for
- Thrombocytopaenia
- What is being tested?
- eltrombopag
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jul 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 26 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Research Triangle Park, North Carolina, 27709
About this study
Official title: A Phase IV Study Evaluating Eltrombopag Concentrations in Breast Milk of Nursing Mothers Taking Eltrombopag
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
- Being tested
- eltrombopag
- Keywords
- eltrombopag, pharmacokinetics, PROMACTA, lactation, milk-only study
- Medical subject headings
- Thrombocytopenia, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eltrombopagDrug
Mothers are taking PROMACTA prescribed by their physician before entering this study. No drug will be administered as part of this study.
| Study group | Role | What they receive |
|---|---|---|
| Study | Experimental | Mothers are taking PROMACTA prescribed by their physician before entering this study. No drug will be administered as part of this study. Receives: Drug: eltrombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast milk eltrombopag concentrations collected from nursing mothers taking eltrombopag
Measured: 24 hours
Secondary outcomes (2)
AEs in infant reported during the 24 hour breast milk collection period
Measured: 24 hours
Plasma eltrombopag concentrations from infant, as data permit (optional)
Measured: 1 sample within 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2010 (estimated)
- Study startMar 2013
- Primary completionJul 2014
- Study completionJul 2014 (estimated)
Why it stopped: 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopaeniaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055600
- Sponsor's protocol ID
- 113101
- Status last verified
- May 2015
- First submitted
- 7 Jan 2010
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Study Evaluating Eltrombopag Concentrations in Breast Milk of Nursing Mothers Taking Eltrombopag
- ClinicalTrials.gov ID
- NCT01055600
- Acronym / sponsor ID
- 113101
- Conditions
- Thrombocytopaenia
- Keywords
- eltrombopag, pharmacokinetics, PROMACTA, lactation, milk-only study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: 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
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (estimated)
- First posted
- 25 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study | Experimental | Drug: eltrombopagMothers are taking PROMACTA prescribed by their physician before entering this study. No drug will be administered as part of this study. |
Who may qualify
- Ages
- 4 to 26 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eltrombopagMothers are taking PROMACTA prescribed by their physician before entering this study. No drug will be administered as part of this study. | Drug | Study |
Primary outcome
Breast milk eltrombopag concentrations collected from nursing mothers taking eltrombopag
Time frame: 24 hours
2 secondary outcomes
AEs in infant reported during the 24 hour breast milk collection period
Time frame: 24 hours
Plasma eltrombopag concentrations from infant, as data permit (optional)
Time frame: 1 sample within 2 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing eltrombopag in people with Thrombocytopaenia, run by GlaxoSmithKline at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast milk eltrombopag concentrations collected from nursing mothers taking eltrombopag (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2015.