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NCT06184503 · ClinicalTrials.gov registry record
Analysis of Velmanase Alfa (Lamzede®)'s Effects in the Body of Children With Alpha-Mannosidosis Under the Age 3
A clinical trial of Alpha-Mannosidosis, sponsored by Chiesi Farmaceutici S.p.A..
- Recruiting
- Registry status
- 5
- Enrollment target
- 2
- Study locations
NCT06184503 is a study of Alpha-Mannosidosis that is actively recruiting participants, run by Chiesi Farmaceutici S.p.A.. The registered enrollment target is 5 participants. The trial reports 2 study locations across 2 states.
The verdict
NCT06184503, a study of Alpha-Mannosidosis, is actively recruiting participants, sponsored by Chiesi Farmaceutici S.p.A..
- RECRUITING
- Registry status
- 5 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Velmanase Alfa
Study Locations (2)
Florida
- Nicklaus Children's Hospital - Miami
South Carolina
- Greenwood Genetic Center - Greenwood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2025-02-19 |
| Est. Completion | 2029-09 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06184503
The ClinicalTrials.gov registry entry for NCT06184503 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Chiesi Farmaceutici S.p.A., which has 30 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Alpha-Mannosidosis appearing as the primary indexed condition, and to 1 intervention - of which Velmanase Alfa is the first listed.
NCT06184503 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Florida, South Carolina.
Frequently Asked Questions
What is clinical trial NCT06184503 about?
NCT06184503 is a clinical study titled "Analysis of Velmanase Alfa (Lamzede®)'s Effects in the Body of Children With Alpha-Mannosidosis Under the Age 3". 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 aft...
What is the current status of trial NCT06184503?
This trial is currently recruiting. The enrollment target is 5 participants. The study started on 2025-02-19. Estimated completion is 2029-09.
What conditions does trial NCT06184503 study?
This clinical trial studies the following conditions: Alpha-Mannosidosis.
What interventions are being tested in trial NCT06184503?
The interventions under investigation include: Velmanase Alfa (DRUG).
Who is sponsoring clinical trial NCT06184503?
This trial is sponsored by Chiesi Farmaceutici S.p.A., which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06184503 being conducted?
This trial has 2 study locations across Florida, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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