5 completed, 1 unknown. 2 Phase 1, 2 Phase 3, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 2 | Completed 2 |
| Phase 3 | 2 | Completed 2 |
| Phase 4 | 2 | Completed 1, Unknown 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Switch Over Study of Biosimilar Agalsidase Beta for Fabry Disease Recombinant human alpha galactosidase A (agalsidase beta), Recombinant human alpha-galactosidase A (agalsidase beta) - Fabry Disease | Phase 3 | Completed | Bio Sidus SA | 20 | 2022-12-13 | 2026-02-18 |
| PK/PD Study of 2 Agalsidase Formulations in Single Dose of 1 mg/kg Administered to Healthy Volunteers as IV Infusion Agalsidase beta from Biosidus 1 mg/kg, Fabrazyme (agalsidase beta) 1 mg/kg - Fabry Disease | Phase 1 | Completed | Bio Sidus SA | 24 | 2021-10-23 | 2025-10-15 |
| Study of HEMAX PFS Versus EPREX/ ERYPO® in Predialysis Chronic Kidney Disease Erythropoietin alfa - Anemia of Chronic Kidney Disease | Phase 3 | Completed | Bio Sidus SA | 43 | 2018-02-28 | 2025-03-20 |
| Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers Epoetin Alfa 40000 UNT/ML - Anemia | Phase 1 | Completed | Bio Sidus SA | 24 | 2016-09-01 | 2020-02-12 |
| Clinical Comparison of Efficacy and Safety of Two Teriparatide Formulations: Osteofortil and Forteo Teriparatide (rDNA origin) - Postmenopausal Osteoporosis With Pathological Fracture | Phase 4 | Unknown | Bio Sidus SA | 110 | 2013-06-01 | 2014-01-22 |
| Epoetin Alfa (Hemax®) Phase IV Study in Chemotherapy Induced Anemia Epoetin alfa - Antineoplastic Chemotherapy Induced Anemia | Phase 4 | Completed | Bio Sidus SA | 30 | 2011-06-01 | 2016-04-07 |
Anemia (3) · Fabry Disease (2) · Renal Insufficiency, Chronic (1)
agalsidase beta (2) · Epoetin Alfa (1) · Teriparatide (1)
Argentina (5) · Paraguay (1)
Diego Ambrogetti, MD (1) · Eduardo Pirotzky, MD (1) · Roberto Diez, MD (1)