Hydoxyurea Exposure in Lactation A Pharmacokinetics Study (HELPS)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 8/15/2018 |
| Start Date: | October 2016 |
| End Date: | November 2019 |
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
single dose to lactating women
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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