| Idefirix (imlifidase) / Hansa Biopharma, Sarepta Therap |
2021-002640-70: Study in highly sensitised kidney transplant patients with a high degree of antibodies against the donor's kidney to see the efficacy and safety of imlifidase to temporarily remove the antibodies and enable the transplantation. |
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| Not yet recruiting | 3 | 150 | Europe | Imlifidase, [Not applicable], Powder for concentrate for solution for infusion, Idefirix | Hansa Biopharma AB, Hansa Biopharma AB | end stage chronic kidney disease (CKD), are highly sensitized and placed on the kidney transplant list awaiting a kidney transplant., Body processes [G] - Immune system processes [G12] | | | | |
ConfIdeS, NCT04935177: Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx |
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| Active, not recruiting | 3 | 64 | US | Imlifidase, IdeS, HMED-IdeS, PLEX, Plasma exchange, PE, IVIg, Intravenous immunoglobulin, Anti-CD20 antibodies, Rituximab, Eculizumab, Soliris, Remain on wait list | Hansa Biopharma AB | Kidney Transplantation in Highly Sensitized Patients | 06/25 | 06/25 | | |
PAES, NCT05369975: Efficacy and Safety in Imlifidase Desensitized Kidney Tx Patients, Including Two Non-Comparative Reference Cohorts |
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| Recruiting | 3 | 225 | Europe, RoW | Imlifidase, IdeS, HMED-IdeS, Normal Transplantation Routine | Hansa Biopharma AB | Kidney Transplantation in Highly Sensitized Patients | 12/24 | 12/24 | | |
| Recruiting | 3 | 50 | Europe, US, RoW | Imlifidase, IdeS, HMED-IdeS, Plasma exchange (PLEX), PE, Cyclophosphamide (CYC), Glucocorticoids | Hansa Biopharma AB | Anti-Glomerular Basement Membrane Disease, Anti-Glomerular Basement Membrane Antibody Disease, Goodpasture Syndrome, Good Pasture Syndrome | 06/25 | 11/26 | | |
PAES-LTFU, NCT05937750: A Long-term Follow-up Trial of Patients Previously Treated With Imlifidase Prior to Kidney Transplantation and a Non-comparative Transplanted Patient Group |
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| Recruiting | 3 | 150 | Europe, RoW | Imlifidase administered in the 20-HMedIdeS-19 (PAES) study, IdeS, HMED-IdeS, Idefirix, Best available treatment administered in the 20-HMedIdeS-19 (PAES) study | Hansa Biopharma AB | Long Term Efficacy and Safety | 12/28 | 12/28 | | |
2018-001059-12: A clinical study investigating the safety and effect of Imlifidase (IdeS) in patients with Guillain-Barré Syndrome (GBS) |
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| Not yet recruiting | 2 | 30 | Europe | Imlifidase, Imlifidase, Powder for concentrate for solution for infusion, Idefirix | Hansa Biopharma AB, Hansa Biopharma AB | Guillain-Barré Syndrome (GBS), Guillain-Barré Syndrome (GBS), Diseases [C] - Immune System Diseases [C20] | | | | |
NCT03897205 / 2018-000022-66: An Efficacy and Safety Study of Imlifidase in Treatment of Antibody-Mediated Rejection in Kidney Transplant Patients |
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| Completed | 2 | 30 | Europe, US, RoW | Imlifidase, HMED-IdeS, IdeS, IgG endopeptidase, Plasma Exchange | Hansa Biopharma AB | Kidney Transplant Rejection | 05/22 | 11/22 | | |
2021-004706-22: Imlifidase for the treatment of autoimmune-mediated small blood vessel inflammation Imlifidase zur Behandlung von autoimmun-vermittelter Entzündung der kleinen Blutgefäße |
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| Not yet recruiting | 2 | 10 | Europe | Idefirix, Powder for concentrate for solution for infusion, Idefirix | Charité - Universitätsmedizin Berlin, Hansa Biopharma | Anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis with severe diffuse alveolar hemorrhage Anti-Neutrophile cytoplasmatische Antikörper (ANCA) assoziierte Vaskulitis mit schwerer diffuser alveolärer Hämorrhagie, Auto-immune inflammation of the lungs with severe bleeding Auto-immun vermittelte Entzündung der Lunge mit schwerer Blutung, Diseases [C] - Immune System Diseases [C20] | | | | |
NCT05049850: A Study to Investigate DSA Rebound in Patients Treated with Imlifidase Prior to Transplantation |
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| Terminated | 2 | 3 | NA | Imlifidase, IdeS, HMED-IdeS | Hansa Biopharma AB | Kidney Transplantation in Highly Sensitized Patients | 02/24 | 05/24 | | |
NCT03943589: A Study of Imlifidase in Patients With Guillain-Barré Syndrome |
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| Completed | 2 | 30 | Europe | Imlifidase, Hansa Medical-Immunoglobulin G degrading enzyme of Streptococcus pyogenes (HMED-IdeS), IdeS, IgG endopeptidase | Hansa Biopharma AB | Guillain-Barré Syndrome (GBS) | 02/24 | 02/24 | | |
| Recruiting | 2 | 10 | Europe | Imlifidase, IdeS, HMED-IdeS | Hansa Biopharma AB | Kidney Transplantation in Highly Sensitized Patients | 09/24 | 09/29 | | |
NCT06518005: Efficacy and Safety of GNT0003 Following Imlifidase Pre-treatment in Severe Crigler-Najjar Syndrome |
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| Not yet recruiting | 2 | 3 | Europe | Imlifidase, GNT0003 | Genethon, Hansa Biopharma AB | Crigler-Najjar Syndrome | 09/26 | 09/30 | | |
| Not yet recruiting | 2 | 10 | NA | Imlifidase | Fundacion Clinic per a la Recerca Biomédica | Kidney Transplant Candidates | 07/26 | 12/26 | | |
2022-003407-15: An Open-Label, Systemic Gene Delivery Study to Evaluate the Safety, Tolerability and Expression of SRP-9001 in association with imlifidase in Subjects with Duchenne Muscular Dystrophy with pre-existing Antibodies to rAAVrh74 Estudio abierto de liberación génica sistémica para evaluar la seguridad, la tolerabilidad y la expresión de SRP-9001 en asociación con imlifidasa en sujetos con distrofia muscular de Duchenne con anticuerpos preexistentes contra rAAVrh74 |
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| Not yet recruiting | 1 | 6 | Europe | Imlifidase, SRP-9001, Solution for infusion, Powder for concentrate for solution for infusion, Idefirix | Sarepta Therapeutics, Inc, Sarepta Therapeutics, Inc | Duchenne muscular dystrophy Distrofia muscular de Duchenne, Duchenne muscular dystrophy Distrofia muscular de Duchenne, Diseases [C] - Nervous System Diseases [C10] | | | | |
NCT06241950: A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) Following Imlifidase Infusion in Participants With Duchenne Muscular Dystrophy (DMD) Determined to Have Pre-existing Antibodies to Recombinant Adeno-Associated Virus Serotype (rAAVrh74) |
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| Enrolling by invitation | 1 | 6 | Europe | delandistrogene moxeparvovec, SRP-9001, delandistrogene moxeparvovec-rokl, ELEVIDYS, imlifidase, Idefirix | Sarepta Therapeutics, Inc., Hansa Biopharma AB | Duchenne Muscular Dystrophy | 01/25 | 09/26 | | |
NCT03611621: A Follow up Study of Patients Treated With Imlifidase Prior to Kidney Transplantation |
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| Completed | N/A | 39 | Europe, US | Imlifidase, IdeS, HMED-IdeS | Hansa Biopharma AB | Kidney Transplant Failure and Rejection | 02/23 | 02/23 | | |
| Terminated | N/A | 18 | Europe | Imlifidase, IdeS, HMED-IdeS | Hansa Biopharma AB | Kidney Transplant Rejection | 03/23 | 03/23 | | |
ConfIdeSLTFU, NCT05714514: Survival and Dialysis Independency in Highly Sensitized Patients After Desensitization With Imlifidase and Tx of Kidneys |
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| Recruiting | N/A | 64 | US | Imlifidase administered in the ConfIdeS study, IdeS, HMED-IdeS, Best available treatment administered in the ConfIdeS study | Hansa Biopharma AB | Kidney Transplantation in Highly Sensitized Patients | 12/27 | 12/29 | | |
