Pharmacokinetics of Oral Hydroxyurea Solution

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

January 3, 2019

Primary Completion Date

May 19, 2021

Study Completion Date

December 29, 2021

Conditions
Sickle Cell DiseaseSickle-Cell; Hemoglobin Disease, ThalassemiaSickle Cell-beta-thalassemiaSickle 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.

Trial Locations (6)

Unknown

Dr Angela E Rankine- Mullings, Kingston

Birmingham Women's and Children's NHS Foundation Trust, Birmingham

Alder Hey Children's NHS Foundation Trust, Liverpool

Evelina London Children's Hospital, London

King's College Hospital NHS Foundation Trust, London

The Royal London Children's Hospital, Barts Health NHS Trust, London

Sponsors
All Listed Sponsors
lead

Nova Laboratories Limited

INDUSTRY

NCT03763656 - Pharmacokinetics of Oral Hydroxyurea Solution | Biotech Hunter | Biotech Hunter