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NCT03180840 · ClinicalTrials.gov registry record · Phase 3
Safety, Efficacy, & PK of PRX-102 in Patients With Fabry Disease Administered Intravenously Every 4 Weeks
A Phase 3 study, sponsored by Protalix.
- Completed
- Registry status
- Phase 3
- Development phase
- 30
- Enrollment target
NCT03180840: Completed Phase 3 study, sponsored by Protalix.
NCT03180840 is a Phase 3 study that has completed, run by Protalix. The registered enrollment target is 30 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03180840, a Phase 3 study, has completed, sponsored by Protalix.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 30 participants
- Enrollment target
Study Summary
This open-label switchover study will assess the safety, efficacy, and pharmacokinetics of pegunigalsidase alfa (PRX-102) 2 mg/kg administered every 4 weeks for 52 weeks in Fabry patients previously treated with ERT: agalsidase alfa or agalsidase beta for at least 3 years. Safety and efficacy exploratory endpoints will be evaluated throughout the study period and pharmacokinetics will be obtained on Day 1 and Week 52.
Primary Outcome
Results represent the number of treatment-emergent adverse events (TEAE) that were considered possibly, probably, or definitely related to treatment.
Interventions
- BIOLOGICAL Pegunigalsidase alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-07-10 |
| Est. Completion | 2020-08-01 |
| Phase | Phase 3 |
What the finished NCT03180840 record still lists
NCT03180840 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Pegunigalsidase alfa is the first listed.
NCT03180840 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03180840 about?
NCT03180840 is a clinical study titled "Safety, Efficacy, & PK of PRX-102 in Patients With Fabry Disease Administered Intravenously Every 4 Weeks". This open-label switchover study will assess the safety, efficacy, and pharmacokinetics of pegunigalsidase alfa (PRX-102) 2 mg/kg administered every 4 weeks for 52 weeks in Fabry patients previously treated with ERT: agalsidase alfa or agalsidase beta for at least 3 years. Safety and efficacy explor...
What is the current status of trial NCT03180840?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 30 participants. The study started on 2017-07-10. Estimated completion is 2020-08-01.
What interventions are being tested in trial NCT03180840?
The interventions under investigation include: Pegunigalsidase alfa (BIOLOGICAL).
Who is sponsoring clinical trial NCT03180840?
This trial is sponsored by Protalix, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03180840's enrollment target sits among peer trials
30 1917th of 2000 higher than 68 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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