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

Outcome

Met primary endpoint

paper The results established bioequivalence between rFVIII-Fc (AryoGen Pharmed Company) and Elocta®, based on the DNAUC as the primary outcome PMID 39934428 ↗

paper the ratio of test and reference products was calculated to be 108.56 (90% confidence interval 104.88 to 112.37), falling within the pre-defined equivalence margin of 80-125%. PMID 39934428 ↗

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

Evaluation	Drug	Modality	Dose	Route
Subject	rFVIIIFc	Protein / enzyme biologic	50 iu/kg	Intravenous

Indications