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Analysis of Velmanase Alfa (Lamzede®)'s Effects in the Body of Children With Alpha-Mannosidosis Under the Age 3

Study acronym: LAMPO(0-3)
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date changed from estimate of Feb 2025 to Feb 19, 2025v7
  2. Start date: Dec 2024 to Feb 2025 Site details revised at 1 of 2 sitesv6 Show 1 more changeShow less
    • Site details revised at 1 of 2 sites
  3. Start date: Oct 2024 to Dec 2024 Study sites: 1 to 2v5 Show 1 more changeShow less
    • Study sites: 1 to 2
  4. Eligibility criteria shortened, about 13 wordsv4 See this version in full on ClinicalTrials.gov ↗
  5. Re-verified, no change to tracked fieldsv3
  6. Trial status: Not Yet Recruiting to Recruiting Start date: May 2024 to Oct 2024 · Study sites: 0 to 1v2 Show 2 more changesShow less
    • Start date: May 2024 to Oct 2024
    • Study sites: 0 to 1
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The goal of this observational study is to learn the effects of the drug velmanase alfa (Lamzede®) in the bodies of children under the age of 3 with Alpha-Mannosidosis. The main questions it aims to answer are: * study the effect of velmanase alfa on a marker of the disease called GlcNAc(Man)2 after one year of therapy * explore how the child's body reacts to velmanase alfa during the therapy The parents or legal guardians of participants will be asked to provide the results of analyses performed in the routine clinical setting related to the participant's general health and the administration of velmanase alfa. Additional data will be extracted from other observational sponsored studies/registries, compassionate use programs, investigator-initiated studies (IIS), and published case reports (presented in the literature) if existing.
Trial Details
NCT Number NCT06184503
Lead Sponsor Chiesi Farmaceutici S.p.A.
Conditions Alpha-Mannosidosis
Enrollment 5 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov