Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03566017 · ClinicalTrials.gov registry record · Phase 3
Open Label Extension Study of 1 mg/kg Pegunigalsidase Alfa Every 2 Weeks in Patients With Fabry Disease
A Phase 3 study, sponsored by Chiesi Farmaceutici S.p.A..
- Completed
- Registry status
- Phase 3
- Development phase
- 97
- Enrollment target
NCT03566017 is a Phase 3 study that has completed, run by Chiesi Farmaceutici S.p.A.. The registered enrollment target is 97 participants.
The verdict
NCT03566017, a Phase 3 study, has completed, sponsored by Chiesi Farmaceutici S.p.A..
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 97 participants
- Enrollment target
Study Summary
The objective of CLI-06657AA1-04 (formerly PB-102-F60) was to evaluate the long-term safety, tolerability, and efficacy parameters of 1 mg/kg pegunigalsidase alfa administered intravenously every other week in adult Fabry patients who had successfully completed studies PB-102-F20, PB-102-F30, or at least 48 months in study PB-102-F03.
Interventions
- DRUG pegunigalsidase alfa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2018-09-16 |
| Est. Completion | 2025-01-21 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03566017
The ClinicalTrials.gov registry entry for NCT03566017 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 97 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 0 conditions, and to 1 intervention - of which pegunigalsidase alfa is the first listed.
NCT03566017 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03566017 about?
NCT03566017 is a clinical study titled "Open Label Extension Study of 1 mg/kg Pegunigalsidase Alfa Every 2 Weeks in Patients With Fabry Disease". The objective of CLI-06657AA1-04 (formerly PB-102-F60) was to evaluate the long-term safety, tolerability, and efficacy parameters of 1 mg/kg pegunigalsidase alfa administered intravenously every other week in adult Fabry patients who had successfully completed studies PB-102-F20, PB-102-F30, or at ...
What is the current status of trial NCT03566017?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 97 participants. The study started on 2018-09-16. Estimated completion is 2025-01-21.
What interventions are being tested in trial NCT03566017?
The interventions under investigation include: pegunigalsidase alfa (DRUG).
Who is sponsoring clinical trial NCT03566017?
This trial is sponsored by Chiesi Farmaceutici S.p.A., which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.