24 Participants Needed

Infigratinib for Dwarfism

(HCH Trial)

Recruiting at 21 trial locations
Age: < 65
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: QED Therapeutics, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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, of who have completed at least 26 weeks of participation in QED-sponsored ACCEL (QBGJ398-004).

Eligibility Criteria

This trial is for children with Hypochondroplasia (HCH), a form of dwarfism that affects bone growth. Participants must have completed at least 26 weeks in a prior ACCEL study and are now continuing treatment to assess further effects.

Inclusion Criteria

Participants and parent(s), legal guardian(s), or caregiver(s) are willing and able to comply with study visits and study procedures
Signed informed consent
I am between 3 and 18 years old and still growing.
See 7 more

Exclusion Criteria

Participants who have ACH or a short stature condition other than HCH
Allergy to any components of the study drug
Pregnant or breastfeeding at the screening visit or planning to become pregnant (self or partner) at any time during the study
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Treatment Details

Interventions

  • Infigratinib
Trial OverviewThe trial is testing two different doses of Infigratinib, an experimental medication, to see how effective and safe it is for treating HCH in children. It's part of a larger Phase 2/3 study following initial treatment results.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Phase 2 Cohort 2Experimental Treatment1 Intervention
infigratinib (0.25 mg/kg/day)
Group II: Phase 2 Cohort 1Experimental Treatment1 Intervention
infigratinib (0.128 mg/kg/day)

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Who Is Running the Clinical Trial?

QED Therapeutics, Inc.

Lead Sponsor

Trials
11
Recruited
1,200+