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By invitation only Phase 2 NCT07393373

Open-Label, Long-Term, Extension Study of Infigratinib in Children With Hypochondroplasia

Phase 2 – studying effectiveness and dosage
Conditions: Hypochondroplasia

Sponsor: QED Therapeutics, a BridgeBio company

trial.available_in: БГ
Overview
Phase 2, multicenter, OLE study to evaluate the long-term safety, tolerability, and efficacy of infigratinib, an FGFR (fibroblast growth factor receptor) 1-3-selective tyrosine kinase inhibitor, in participants with Hypochondroplasia (HCH) who previously completed ACCEL 2/3, and potentially additional participants who completed ACCEL. Participants rolling over directly from the observational ACCEL study must have had at least a 6-month period of growth assessment in that study.
Who can participate
Inclusion Criteria: * Inclusion Criteria for Participants Rolling Over from ACCEL 2/3 1. Pediatric participants with HCH who have completed ACCEL 2/3 2. Negative pregnancy test in girls ≥10 years of age or girls of any age who have experienced menarche Exclusion Criteria: * Exclusion Criteria for Participants Rolling Over from ACCEL 2/3 1. Participant has concurrent medical condition that, in the view of the PI and/or sponsor, would interfere with study participation or safety evaluations 2. Participants who developed a medical condition that requires the initiation of treatment with a prohibited medication 3. Participants who prematurely discontinued ACCEL 2/3 4. Participants who have reached final height or near final height 5. Current participation in an ongoing clinical study with a sponsor other than QED
Locations 10
Australia (1)
Murdoch Children's Research Institute
Parkville , Victoria
Canada (1)
London Health Sciences Centre - Children's Hospital of Western Ontario
London , Ontario
France (1)
Hôpital Femme Mère Enfant
Bron
Norway (1)
Haukeland University Hospital
Bergen
Portugal (1)
Hospital Pediátrico de Coimbra
Coimbra
Singapore (1)
KK Women's and Children's Hospital
Singapore
Spain (1)
UCA Hospital MiKS
Vitoria-Gasteiz
Sweden (1)
Astrid Lindgren Children's Hospital
Solna
United Kingdom (1)
The Portland Hospital for Women and Children
London , England
United States (1)
UCSF Benioff Children's Hospital
Oakland , California
Technical details
Status
By invitation only
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
3 Years
Maximum age
18 Years
Healthy volunteers
No
Start date
21.04.2026
Completion date
31.05.2036
Registry ID
NCT07393373
Source
anzctr
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