[The efficacy and safety of eculizumab biosimilar in patients with paroxysmal nocturnal hemoglobinuria. Results of a phase III randomized open-label comparative clinical trial].
Alexander Dmitrievich KulaginBulat A BakirovIgor L DavydkinI V ElykomovTatyana S KonstantinovaAlexander V KorobkinM V KosinovaVadim I MazurovN V MinaevaA V ProidakovVadim V PtushkinY V ShatokhinYulia N LinkovaArina V Zinkina-OrikhanMaria A MorozovaPublished in: Terapevticheskii arkhiv (2021)
The study established the equivalent efficacy of biosimilar product Acveris and referent eculizumab product with the evidence of effective suppression of intravascular hemolysis in PNH patients along with a comparable favorable safety profile.
Keyphrases
- phase iii
- open label
- clinical trial
- phase ii
- double blind
- placebo controlled
- end stage renal disease
- phase ii study
- study protocol
- chronic kidney disease
- ejection fraction
- blood pressure
- atrial fibrillation
- newly diagnosed
- patient reported outcomes
- peritoneal dialysis
- coronary artery
- physical activity
- rectal cancer
- sleep apnea