drugset / Trial / NCT03566017

Open Label Extension Study of 1 mg/kg Pegunigalsidase Alfa Every 2 Weeks in Patients With Fabry Disease

NCT03566017

Phase 3 Completed 97 enrolled Chiesi Farmaceutici S.p.A.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2018-09-16
Primary completion
2025-01-21
Completion
2025-01-21

Drugs

EvaluationDrugModalityDoseRoute
Subject pegunigalsidase alfa Protein / enzyme biologic 1 mg/kg Intravenous

Indications