rFVIII-Fc (Produced by AryoGen Pharmed Co.) Pharmacokinetic Study

Summary

The study is designed as a randomized, two-armed, double-blind, single-dose, crossover, two-sequence, active-controlled, multi-center, bioequivalence clinical trial with a primary endpoint of dose-normalized area under the curve (dnAUC last)

Timeline

Start

2023-07-22

Primary completion

2023-09-27

Completion

2023-09-27

Publications

• Eghbali A, Eshghi P, Toogeh G, Alavi S, Badiei Z, Ghanavat M, Bordbar M, Bazrafshan A, Karimi K, Ahmadinejad M, Sabzvari A, Kafi H. A randomized, two-armed, double-blind, single-dose, cross-over, bioequivalence clinical trial to compare pharmacokinetic parameters and safety of recombinant human factor VIII with Fc fusion produced by AryoGen Pharmed Company versus Elocta(R) (reference product) in previously treated patients with severe haemophilia A. Ann Hematol. 2025 Feb;104(2):1195-1202. doi: 10.1007/s00277-025-06242-z. Epub 2025 Feb 12.

Drugs

Indications