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NCT02990598: HELPS

Hydoxyurea Exposure in Lactation A Pharmacokinetics Study (HELPS)

Completed Last updated 26 August 2019
What this trial tests

trial in Sickle Cell Anemia in 16 participants. Completed in 19 June 2018.

Timeline
20 March 2017
Primary endpoint
19 June 2018
19 June 2018

Quick facts

Lead sponsorChildren's Hospital Medical Center, Cincinnati
StatusCompleted
Study typeOBSERVATIONAL
Enrollment16
Start date20 March 2017
Primary completion19 June 2018
Estimated completion19 June 2018
Sites1 location across United States

Conditions studied

Sponsor

Children's Hospital Medical Center, Cincinnati

Who can join

Adults 18 to 99, female only, with Sickle Cell Anemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The Evolving Pharmacotherapeutic Landscape for the Treatment of Sickle Cell Disease.
    Ballas SK. · · 2020 · cited 36× · PMID 31934320 · DOI 10.4084/mjhid.2020.010

Verify or expand the search:

Other recruiting trials for Sickle Cell Anemia

Currently open trials in the same condition.

Other Children's Hospital Medical Center, Cincinnati trials

Trials by the same sponsor.

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing