Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Burosumab in Patients Less Than 1 Year of Age

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

February 26, 2020

Primary Completion Date

October 4, 2023

Study Completion Date

March 6, 2024

Conditions
X-linked Hypophosphatemia (XLH)
Interventions
DRUG

Burosumab

Burosumab is a sterile clear colourless to slightly yellow and preservative free solution supplied in single use 5ml vials containing 1 mL of Burosumab at a concentration of 10mg/mL,20 mg/mL or 30mg/mL, administered by SC injections every 2 weeks.

Trial Locations (9)

Unknown

Kepler Universitaetsklinikum GmbH, Linz

Centre de reference des maladies renales rares-Hospices Civils de Lyon-Hopital Femme Mere Enfant, Lyon

Hopital Kremlin APHP, Paris

Ospedale Pediatrico Bambino Gesù, Rome

Hospital Virgen del Rocío, Seville

Karolinska University Hospital, Stockholm

Evelina London Children's Hospital - Guy's & St Thomas' NHS Foundation Trust, London

Great Ormond Street Hospital, London

Royal Manchester Children's Hospital, Manchester

All Listed Sponsors
lead

Kyowa Kirin Pharmaceutical Development Ltd

INDUSTRY

NCT04188964 - Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of Burosumab in Patients Less Than 1 Year of Age | Biotech Hunter | Biotech Hunter