Clinical Trials Logo
  1. Home
  2. Sickle Cell Anemia
  3. NCT02990598
  4. Details
NCT02990598 Clinical Trial

Hydoxyurea Exposure in Lactation A Pharmacokinetics Study (HELPS)

Sickle Cell Anemia Clinical Trial

— HELPS  

Official title:
Hydoxyurea Exposure in Lactation: A Pharmacokinetics Study (HELPS)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02990598
Other study ID # 2016-7590_HELPS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 20, 2017
Est. completion date June 19, 2018

Study information
Verified date August 2019
Source Children's Hospital Medical Center, Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To examine the pharmacokinetics and distribution of oral hydroxyurea when administered as a single dose to lactating women

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date June 19, 2018
Est. primary completion date June 19, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 99 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio

Sponsors (1)
Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hydroxyurea Concentration Hydroxyurea concentration for each collected specimen will be analyzed and summarized. 31-Dec-2019
See also
  Status Clinical Trial Phase
Completed NCT04134299 - To Assess Safety, Tolerability and Physiological Effects on Structure and Function of AXA4010 in Subjects With Sickle Cell Disease N/A
Completed NCT04581356 - Voxelotor Sickle Cell Exercise Study Phase 4
Completed NCT02712346 - The Role of Endothelin-1 in Sickle Cell Disease Phase 1
Withdrawn NCT02162225 - Study of Beet Juice for Patients With Sickle Cell Anemia Phase 2
Completed NCT01976416 - Novel Use Of Hydroxyurea in an African Region With Malaria Phase 3
Completed NCT01137721 - State Of The Art Functional Imaging In Sickle Cell Disease
Withdrawn NCT00937144 - Endothelial Function in Patients With Sickle Cell Anemia Before and After Sildenafil Phase 4
Terminated NCT01350232 - Treatment of Sickle Cell Anemia With Stem Cell Transplant N/A
Completed NCT00512564 - Clinical and Laboratory Assessment of Iron Overload in Sickle Cell Anemia and Sickle Cell Thalassemia N/A
Completed NCT00512226 - Iron Overload Assesment in Sickle Cell Anemia and Sickle Cell Thalassemia N/A
Completed NCT00004143 - Allogeneic Mixed Chimerism Stem Cell Transplant Using Campath for Hemoglobinopathies & Bone Marrow Failure Syndromes Phase 2
Completed NCT00004412 - Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers Phase 2
Withdrawn NCT01925001 - Phase 2 Study of MP4CO to Treat Vaso-occlusive Sickle Crisis Phase 2
Completed NCT01783990 - Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) Follow-up Observational Study II Protocol
Completed NCT01848691 - Carbon Monoxide Monitor for the Measurement of End-Tidal Carbon Monoxide Levels in Children With or Without Hemolysis N/A
Completed NCT00874172 - Effectiveness of New Analgesic Strategy Compared to the Usal Antalgic Strategy N/A
Completed NCT01000155 - Efficacy of Vorinostat to Induce Fetal Hemoglobin in Sickle Cell Disease Phase 2
Completed NCT00236093 - Extension Study of ACTIQ Treatment for Children and Adolescents With Breakthrough Pain Phase 2
Completed NCT00399074 - Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prevention in Children With Sickle Cell Anemia Phase 3
Completed NCT00004492 - Phase I/II Randomized Study of Hydroxyurea With or Without Clotrimazole in Patients With Sickle Cell Anemia Phase 1/Phase 2