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A Clinical Trial to Investigate Long-term Safety, Tolerability, and Efficacy of Weekly Subcutaneous Doses With TransCon CNP in Children and Adolescents With Achondroplasia

Study acronym: AttaCH
StatusEnrolling by Invitation
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study sites: 18 to 19v9
  2. Minor Study sites: 17 to 18v8
  3. Minor Study sites: 15 to 17v7
  4. Minor Study sites: 13 to 15v6
  5. Minor Study sites: 10 to 13v5
Show 3 earlier versionsHide 3 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv4
  2. Minor Study sites: 7 to 10v3
  3. Minor Trial status: Recruiting to Enrolling by Invitation
    • Study sites: 1 to 7
    v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
TransCon CNP administered once-weekly in children and adolescents with achondroplasia who have completed a prior TransCon CNP clinical trial. Participants who complete a prior TransCon CNP trial and meet all eligibility criteria will be invited to continue into the long-term open label extension trial to receive 100 µg CNP/kg/week of TransCon CNP. Trial treatment will be completed when the participant reaches 16 years of age for females and 18 years of age for males and have femur and tibial epiphyseal closure. TransCon CNP treatment will continue if femur and tibial epiphyseal closure is not confirmed at the age of 16 years for females, and 18 years for males. Treatment with TransCon CNP will be completed once femur and tibial epiphyseal closure is confirmed by radiographic imaging. The trial duration is individual for each trial participant. Visits will occur every 12-14 weeks throughout the trial.
Trial Details
NCT Number NCT05929807
Lead Sponsor Ascendis Pharma Growth Disorders A/S
Conditions
(from sponsor)
Achondroplasia
Related terms Achondroplasia, Dwarfism
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov