Clinical trial
Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal…
NCT02795676 · Protalix, Industry · Completed
Key facts
| NCT number | NCT02795676 |
|---|---|
| Title | Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function |
| Official title | A Randomized, Double Blind, Active Control Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function in Patients With Fabry Disease Previously Treated With Agalsidase Beta |
| Acronym | BALANCE |
| Lead sponsor | Protalix, Industry |
| Collaborators | Chiesi Farmaceutici S.p.A. Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Fabry Disease |
| Intervention type | Biological |
| Interventions | PRX-102 (pegunigalsidase alfa), agalsidase beta |
| Enrollment | 78 |
| Start date | Jun 1, 2016 |
| Primary completion | Oct 1, 2021 |
| Completion | Jul 1, 2022 |
| First posted | Jun 10, 2016 |
| Last update posted | Sep 13, 2023 |
| Countries | Czechia, Finland, France, Hungary, Italy, Netherlands, Norway, Slovenia, Spain, Switzerland, United Kingdom, United States |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: