Sickle Cell AnemiaHELPSNCT02990598
Hydoxyurea Exposure in Lactation A Pharmacokinetics Study (HELPS)
An observational study of Sickle Cell Anemia, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
To examine the pharmacokinetics and distribution of oral hydroxyurea when administered as a single dose to lactating women Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Anemia
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2017to 19 Jun 2018
- Phase
- Observational
- 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 18 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Controls and Women taking Hydroxyurea prescribed by treating physician and lactating
Who may be able to join
- Lactating females, ≥ 18.0 years of age, at the time of enrollment
- Willingness to limit the baby's exposure to hydroxyurea through breastmilk, such as healthy volunteers using the "pump and dump" technique or avoiding direct breastfeeding or collection of pumped milk for at least 8 hours after taking the hydroxyurea dose. This applies only to healthy controls or women with sickle cell who are not already taking hydroxyurea. Women with sickle cell already taking hydroxyurea may continue to breastfeed their infants.
Who cannot join
- Persons with known allergies to hydroxyurea
- Failure to sign informed consent, or inability to undergo informed consent process
- Persons for whom it is not feasible or medically advisable to obtain the specimens necessary for this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Hydoxyurea Exposure in Lactation: A Pharmacokinetics Study (HELPS)
To examine the pharmacokinetics and distribution of oral hydroxyurea when administered as a single dose to lactating women
- Conditions
- Sickle Cell Anemia
- Keywords
- Hydroxyurea
- Medical subject headings
- Anemia, Sickle Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydroxyurea Concentration
Hydroxyurea concentration for each collected specimen will be analyzed and summarized.
Measured: 31-Dec-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study start20 Mar 2017
- Primary completion19 Jun 2018
- Study completion19 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell AnemiaStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Russell Ware, MD, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990598
- Sponsor's protocol ID
- 2016-7590_HELPS
- Acronym
- HELPS
- Status last verified
- Aug 2019
- First submitted
- 9 Dec 2016
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydoxyurea Exposure in Lactation: A Pharmacokinetics Study (HELPS)
- ClinicalTrials.gov ID
- NCT02990598
- Acronym / sponsor ID
- HELPS / 2016-7590_HELPS
- Conditions
- Sickle Cell Anemia
- Keywords
- Hydroxyurea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- 19 Jun 2018 (actual)
- Study completion
- 19 Jun 2018 (actual)
- First posted
- 13 Dec 2016 (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.
To examine the pharmacokinetics and distribution of oral hydroxyurea when administered as a single dose to lactating women
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Controls and Women taking Hydroxyurea prescribed by treating physician and lactating
Key inclusion criteria (2 listed)
- Lactating females, ≥ 18.0 years of age, at the time of enrollment
- Willingness to limit the baby's exposure to hydroxyurea through breastmilk, such as healthy volunteers using the "pump and dump" technique or avoiding direct breastfeeding or collection of pumped milk for at least 8 hours after taking the hydroxyurea dose. This applies only to healthy controls or women with sickle cell who are not already taking hydroxyurea. Women with sickle cell already taking hydroxyurea may continue to breastfeed their infants.
Key exclusion criteria (3 listed)
- Persons with known allergies to hydroxyurea
- Failure to sign informed consent, or inability to undergo informed consent process
- Persons for whom it is not feasible or medically advisable to obtain the specimens necessary for this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hydroxyurea Concentration
Time frame: 31-Dec-2019
Hydroxyurea concentration for each collected specimen will be analyzed and summarized.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Russell Ware, MD, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Anemia, run by Children's Hospital Medical Center, Cincinnati 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 26 Aug 2019. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hydroxyurea Concentration (time frame: 31-Dec-2019). 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 26 Aug 2019.