An Interventional Study of Infigratinib in Children With Hypochondroplasia
Condition(s) studied
Investigational drug(s) / intervention(s)
infigratinib 0.128 mg/kg/day: Oral infigratinib 0.128 mg/kg/day
infigratinib 0.25 mg/kg/day: Oral infigratinib 0.25 mg/kg/day
Study summary
ACCEL2/3 is a Phase 2/3 study. The purpose of the Phase 2 portion of the study (ACCEL2/3) is to evaluate the efficacy and safety of infigratinib in children with hypochondroplasia (HCH) receiving infigratinib at one of two doses, who have completed at least 26 weeks of participation in QED-sponsored ACCEL (QBGJ398-004).
Eligibility
Primary outcome measure(s)
- Change from baseline (BL) in Annualized Height Velocity (AHV; cm/year) — 26 weeks
- Incidence, severity, and seriousness of adverse events (AEs) that require dose reduction or discontinuation — at least 26 weeks
Trial sites (24)
| Facility | City | Region | Status |
|---|---|---|---|
| UCSF Benioff Children's Hospital | Oakland | California | |
| Childrens Hospital Colorado | Aurora | Colorado | |
| Children's National Hospital | Washington D.C. | District of Columbia | |
| Johns Hopkins School of Medicine | Baltimore | Maryland | |
| University of Missouri | Columbia | Missouri | |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | |
| Vanderbilt University Medical Center | Nashville | Tennessee | |
| University of Wisconsin Madison - Waisman Center Bone Dysplasia Clinic | Madison | Wisconsin | |
| Murdoch Children's Research Institute - The Royal Children's Hospital Melbourne | Parkville | Victoria | |
| London Health Services Centre - Children's Hospital of Western Ontario | London | Ontario | |
| Children's Hospital of Eastern Ontario Research Institute | Ottawa | Ontario | |
| Université de Montréal - Centre Hospitalier Universitaire Sainte-Justine | Montreal | Quebec | |
| Hôpital Femme Mère Enfant | Bron | France | |
| Hôpital Universitaire Necker-Enfants Malades | Paris | France | |
| Centre Hospitalier Universitaire (CHU) de Toulouse - Hôpital des Enfants | Toulouse | France | |
| Haukeland University Hospital | Bergen | Norway | |
| Paediatric Clinical Research Unit at Oslo University Hospital | Oslo | Norway | |
| Hospital Pediátrico de Coimbra | Coimbra | Portugal | |
| KK Women's and Children's Hospital | Singapore | Singapore | |
| Unidad de Cirugía Artroscopica, Hopsital MIKS | Vitoria-Gasteiz | Spain | |
| Astrid Lindgren Children's Hospital | Solna | Sweden | |
| Manchester University | Manchester | England | |
| Sheffield Children's Hospital | Sheffield | England | |
| Glasgow Clinical Research Facility, Queen Elizabeth University Hospital | Glasgow | Scotland |
More QED Therapeutics, a BridgeBio company trials in Sweden
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06873035 on ClinicalTrials.gov ↗ ← All trials in Sweden