Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 4 study, sponsored by Sanofi.
NCT06019728 is a Phase 4 study that has completed, run by Sanofi. The registered enrollment target is 8 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percent reduction was with respect to the shortest tolerated infusion for the participant. The shortest infusion duration tolerated was the actual shortest duration (highest infusion rate) of a completed infusion tolerated by the participant without experiencing a second infusion associated reaction (IAR). The pre-study infusion duration was derived as the average of the duration of 3 most recent infusions the participant received prior to participating to this study. Percent reduction of infusi
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 |
What the finished NCT06019728 record still lists
NCT06019728 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 5 interventions - of which Acetaminophen is the first listed.
NCT06019728 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06019728's enrollment target sits among peer trials
8 1972nd of 2000 higher than 20 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI