Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05145010 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Extension Study of Infigratinib in Children With Achondroplasia (ACH)

StatusEnrolling by Invitation
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv18
  2. Study sites: 29 to 31v17
  3. Study sites: 24 to 29v16
  4. Re-verified, no change to tracked fieldsv15
  5. Study sites: 23 to 24v14
Show 12 earlier versionsHide 12 earlier versions
  1. Study sites: 22 to 23v13
  2. Study sites: 21 to 22v12
  3. Study sites: 19 to 21v11
  4. Study sites: 18 to 19v10
  5. Enrollment target: 280 to 300
    • Eligibility criteria expanded, about 29 words
    v9
  6. Study sites: 17 to 18v8
  7. Trial status: Recruiting to Enrolling by Invitation
    • Study sites: 13 to 17
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: 13 to 17
    v7
  8. Study sites: 12 to 13v6
  9. Site details revised at 1 of 12 sitesv5
  10. Study sites: 4 to 12
    • Eligibility criteria expanded, about 50 words
    • Secondary endpoints: 10 to 13
    v4
  11. Study sites: 2 to 4v3
  12. Study sites: 1 to 2
    • Start date changed from estimate of Dec 1, 2021 to Dec 6, 2021
    • Secondary endpoints: 9 to 10
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a Phase 2, multicenter, open-label, extension (OLE) study to evaluate the long-term safety, tolerability, and efficacy of infigratinib, an FGFR 1-3-selective tyrosine kinase inhibitor, in subjects with ACH who previously completed a QED-sponsored interventional study, and potentially in additional subjects who are naïve to infigratinib treatment. Quality of Life assessments for this subject population will also be evaluated. Treatment-naïve subjects must have at least a 6-month period of growth assessment in study QBGJ398-001 (PROPEL) and will be enrolled in this OLE study only after a dose to be explored further is identified in Phase 2 Study QBGJ398-201 and subjects are not otherwise eligible to enroll in another QED-sponsored Phase 2 or Phase 3 ACH study.
Trial Details
NCT Number NCT05145010
Lead Sponsor QED Therapeutics, a BridgeBio company
Conditions
(from sponsor)		 Achondroplasia
Related terms Achondroplasia, Bone Diseases, Genetic Diseases, Inborn, Mucopolysaccharidosis IV, Musculoskeletal Diseases, Osteochondrodysplasias
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov