Résultats des études cliniques

Les informations ci-dessous ainsi que les liens correspondant aux données cliniques répondent aux exigences des articles 71 à 73 de l’Ordonnance sur les médicaments (Ordonnance sur les médicaments, OMéd) et complètent les informations publiées en lien avec l’autorisation suisse des médicaments correspondants.

Acalabrutinib (Calquence), 100 mg gélules:

Numéro d’autorisation Swissmedic: 67790
Date d’autorisation Swissmedic: 04.03.2021

Études d’autorisation

ELEVATE-TN (ACE-CL-007): A Randomized, Multicenter, Open-Label, 3 Arm Phase 3 Study of Obinutuzumab in Combination With Chlorambucil, Acalabrutinib (ACP-196) in Combination With Obinutuzumab, and Acalabrutinib Monotherapy in Subjects With Previously Untreated CLL

• EudraCT Nummer: 2014-005582-73
• ClinicalTrials.gov: https://www.clinicaltrials.gov/ct2/show/NCT02475681

ASCEND (ACE-CL-309): A Randomized, Multicenter, Open-Label, Phase 3 Study of Acalabrutinib (ACP-196) Versus Investigator's Choice of Either Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Subjects With R/R Chronic Lymphocytic Leukemia

• EudraCT Nummer: 2015-004454-17
• ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT02970318

Natrii zirconii cyclosilicas (Lokelma), 5 g & 10 mg, Poudre pour suspension buvable:

Numéro d’autorisation Swissmedic: 67851
Date d’autorisation Swissmedic: 16.04.2021

Études d’autorisation

ZS-002: Multicenter, Prospective, Randomized, Placebo-Controlled, Double-blind Dose Escalating Study of Safety, Tolerability and Pharmacodynamics of Zirconium Silicate in Chronic Kidney Disease and Moderate Kidney Dysfunction With Mild Hyperkalemia

• ClinicalTrials.gov: https://www.clinicaltrials.gov/ct2/show/NCT01493024

ZS-003: Multicenter, Two-phase, Multi-dose, Prospective, Randomized, Double-blind, Placebo-Controlled Study of Safety and Efficacy of Microporous, Fractionated, Protonated Zirconium Silicate in Mild to Moderate Hyperkalemia

• ClinicalTrials.gov: https://www.clinicaltrials.gov/ct2/show/NCT01737697

ZS-004: Multicenter, Multi-phase, Multi-dose, Prospective, Double-blind, Placebo-controlled, Maintenance Study of Safety and Efficacy of ZS (Microporous, Fractionated, Protonated Zirconium Silicate) in Hyperkalemia.

• ClinicalTrials.gov: https://www.clinicaltrials.gov/ct2/show/NCT02088073

ZS-004E: Open-label Extension to Study ZS-004 [Phase 3 Multicenter, Multi-phase, Multi-dose, Prospective, Randomized, Double-blind, Placebo-controlled Maintenance Study of Safety Efficacy of ZS (Sodium Zirconium Cycolsilicate) in Hyperkalemia.]

• ClinicalTrials.gov: https://www.clinicaltrials.gov/ct2/show/NCT02107092

ZS-005: Multicenter, Multi-Dose, Open-Label Maintenance of Long-Term Safety and Efficacy of Sodium Zirconium Cyclosilicate (ZS) in Hyperkalemia

• EudraCT Nummer: 2014-004555-31
• ClinicalTrials.gov: https://www.clinicaltrials.gov/ct2/show/NCT02163499

D9480C00006: A Phase 3b, Multicenter, Prospective, Randomized, Double Blind, Placebocontrolled Study to Reduce Incidence of Pre-dialysis Hyperkalemia With Sodium Zirconium Cyclosilicate (DIALIZE)

• EudraCT Nummer: 2017-003029-14
• ClinicalTrials.gov: https://www.clinicaltrials.gov/ct2/show/NCT03303521