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Pharmacokinetics of Oral Hydroxyurea Solution

NCT03763656 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2024-10-28

Study results available
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Summary

An open label, safety and pharmacokinetic study of oral hydroxyurea solution administered to children from 6 months to 17.99 years (i.e. to the day before 18th birthday), with a 12 to 15 month treatment period for each participant. The study treatment duration will be for 6 months at the maximum tolerated dose \[MTD\], which is usually reached by 6 months after initiation of treatment. For patients in whom time to MTD is longer than 6 months or not achieved at all, the maximum duration of study treatment will be 15 months.

Conditions

  • Sickle Cell Disease
  • Sickle-Cell; Hemoglobin Disease, Thalassemia
  • Sickle Cell-beta-thalassemia
  • Sickle Cell Hemoglobin C

Interventions

DRUG

Oral Hydroxyurea (100 mg/mL) Solution

Participants received Oral Hydroxyurea 15 mg/kg once daily. Escalated by 5 mg/kg/day every 8-12 weeks until maximum tolerated dose achieved, up to a maximum 35 mg/kg/day.

Sponsors & Collaborators

  • Nova Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Angela E Rankine- Mullings, MD · University of the West Indies, Mona, Kingston, Jamaica

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-03
Primary Completion
2021-05-19
Completion
2021-12-29

Countries

  • Jamaica
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03763656 on ClinicalTrials.gov