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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 is a Phase 3 study that has completed, run by Protalix. The registered enrollment target is 30 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03180840
The ClinicalTrials.gov registry entry for NCT03180840 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Protalix, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pegunigalsidase alfa is the first listed.
NCT03180840 reports 0 study locations.
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.
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