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NCT06019728 · ClinicalTrials.gov registry record · Phase 4
A Prospective Study to Investigate Safety and Tolerability of Shorter Infusion of Fabrazyme
A Phase 4 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 8
- Enrollment target
NCT06019728 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 8 participants.
The verdict
NCT06019728, a Phase 4 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 8 participants
- Enrollment target
Study Summary
This Phase 4 study will evaluate the safety and tolerability of Fabrazyme at current approved dose with increases in the infusion rate and reduced infusion volume. This study aims to generate data to provide the guidance on how infusion rate can be safely increased and minimize the burden of the life-long treatment with Fabrazyme.
Interventions
- DRUG Acetaminophen
- DRUG Dexamethasone
- DRUG Montelukast
- DRUG Diphenhydramine
- DRUG AGALSIDASE BETA (GZ419828)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2023-11-10 |
| Est. Completion | 2024-10-25 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06019728
The ClinicalTrials.gov registry entry for NCT06019728 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Acetaminophen is the first listed.
NCT06019728 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06019728 about?
NCT06019728 is a clinical study titled "A Prospective Study to Investigate Safety and Tolerability of Shorter Infusion of Fabrazyme". This Phase 4 study will evaluate the safety and tolerability of Fabrazyme at current approved dose with increases in the infusion rate and reduced infusion volume. This study aims to generate data to provide the guidance on how infusion rate can be safely increased and minimize the burden of the lif...
What is the current status of trial NCT06019728?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 8 participants. The study started on 2023-11-10. Estimated completion is 2024-10-25.
What interventions are being tested in trial NCT06019728?
The interventions under investigation include: Acetaminophen (DRUG), Dexamethasone (DRUG), Montelukast (DRUG), Diphenhydramine (DRUG), AGALSIDASE BETA (GZ419828) (DRUG).
Who is sponsoring clinical trial NCT06019728?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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