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A Study to Evaluate Long-Term Safety, Tolerability, & Efficacy of BMN 111 in Children With Achondroplasia (ACH)

Study acronym: ACH
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. 6 versions Re-verified since Dec 9, 2022, no change to tracked fieldsv16-v21
  2. Primary completion date: Oct 2022 to Dec 2027
    • Study completion date: Oct 2022 to Feb 2028
    • Secondary endpoints: 3 to 4
    v15
  3. 3 versions Re-verified since Mar 17, 2021, no change to tracked fieldsv12-v14
  4. Secondary endpoints: details revised at 3 of 3 entriesv11
  5. 5 versions Re-verified since Apr 4, 2019, no change to tracked fieldsv6-v10
Show 4 earlier versionsHide 4 earlier versions
  1. Study completion date: Dec 2022 to Oct 2022
    • Eligibility criteria expanded, about 42 words
    • Secondary endpoints: details revised at 3 of 3 entries
    v5
  2. Eligibility criteria expanded, about 29 wordsv4
  3. Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Start date: Jan 2016 to Jan 26, 2016
    • Eligibility criteria shortened, about 12 words
    v3
  4. Enrollment target: 46 to 30
    • Eligibility criteria expanded, about 29 words
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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, Open-Label, Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of BMN 111 in Children with Achondroplasia. The primary objective is to evaluate the long-term safety and tolerability of daily SC injections of BMN 111 in children with ACH who have completed two years of treatment in the 111-202 study.
Trial Details
NCT Number NCT02724228
Lead Sponsor BioMarin Pharmaceutical
Conditions
(from sponsor)		 Achondroplasia
Related terms Achondroplasia, Bone Diseases, Bone Diseases, Developmental, Dwarfism
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov