Extension Study of Infigratinib in Children With Achondroplasia (ACH)

PHASE2Enrolling by invitationINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

December 6, 2021

Primary Completion Date

December 1, 2031

Study Completion Date

February 1, 2032

Conditions
Achondroplasia
Interventions
DRUG

Infigratinib

Infigratinib minitablets or sprinkle capsules to be administered by mouth. In subjects that completed a prior study with infigratinib, the starting dose will be the same as the last dose received in the prior interventional study with infigratinib. Infigratinib dose may be adjusted to 0.25 mg/kg/day (the dose selected to be explored further in the dose escalation portion of Phase 2 study QBGJ398-201 (PROPEL 2)).

DRUG

Infigratinib

Infigratinib sprinkle capsules to be administered by mouth. Starting dose for the subjects naïve to Infigratinib will be 0.25 mg/kg/day (the dose selected to be explored further in the dose escalation portion of Phase 2 study QBGJ398-201 (PROPEL 2)).

Trial Locations (29)

3052

Murdoch Children's Hospital, Parkville

5021

Haukeland University Hospital, Bergen

19803

Nemours Alfred I. Dupont Hospital for Children, Wilmington

21205

Johns Hopkins University, Baltimore

28046

Hospital Universitario La Paz, Madrid

29010

Hospital Universitario Virgen de la Victoria, Málaga

31300

Hopital des Enfants, Toulouse

37232

Vanderbilt University Medical Center, Nashville

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

53705

University Hospital and UW Health Clinics, Madison

65212

University of Missouri, Columbia

69500

Hopital Femme Mere Enfant, Lyon

75743

Hopital Necker-Enfants Malades, Paris

80045

Children's Hospital Colorado, Aurora

94609

USCF Benioff Children's Hospital, Oakland, Oakland

229899

KK Women's and Children's Hosptial, Singapore

C1245AAM

Hospital de Pediatría SAMIC Prof. Dr. Juan P. Garrahan, Ciudad Autonoma Buenos Aires

T6C 2B7

Stollery Children's Hospital, Edmonton

N6A 5W9

Children's Hospital - London Health Sciences Centre, London

K1H 8L1

Children's Hospital of Eastern Ontario, Ottawa

H3T 1C5

Centre Hospitalier Universitaire Sainte-Justine, Montreal

0372

Oslo University Hospital, Oslo

01012

Hospital Vithas San José, Vitoria-Gasteiz

B5 6NH

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

BS2 8AE

University Hospitals Bristol and Weston NHS Foundation Trust, Bristol

G12 0XH

Queen Elizabeth University Hospital, Glasgow

SE1 7EH

St. Thomas' Hospital, London

M13 9WL

Manchester University Children's Hospital, Manchester

S10 2TH

Sheffield Children's Hospital, Sheffield

All Listed Sponsors
lead

QED Therapeutics, Inc., a Bridgebio company

INDUSTRY