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® (Reference Product) in Previously Treated Patients With Severe Haemophilia A

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® (Reference Product) in Previously Treated Patients With Severe Haemophilia A Publisher Pubmed

Eghbali A¹ ; Eshghi P² ; Toogeh G³ ; Alavi S² ; Badiei Z⁴ ; Ghanavat M⁵ ; Bordbar M⁶ ; Bazrafshan A⁷ ; Karimi K³ ; Ahmadinejad M⁸ ; Sabzvari A⁹ ; Kafi H¹⁰

Show Affiliations

1. Aliasghar Clinical Research Development Center, Iran University of Medical Sciences, Tehran, Iran
2. Pediatric Congenital Hematologic Disorders Research Center, Research Institute for Children’s Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran
3. Thrombosis Hemostasis Research Center, Tehran University of Medical Sciences, Tehran, Iran
4. Hemophilia and Thalassemia Center of Mashhad (Sarvar Clinic), Mashhad University of Medical Sciences, Mashhad, Iran
5. Isfahan University of Medical Sciences, Isfahan, Iran
6. Hematology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
7. Hemophilia Center, Dastgheib Hospital, Shiraz, Iran
8. Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran
9. CinnaGen Medical Biotechnology Research Center, Alborz University of Medical Sciences, Karaj, Iran
10. Medical Department, Orchid Pharmed Company, Tehran, Iran

Source: Annals of Hematology Published:2025

Abstract

This clinical study evaluates the bioequivalence of recombinant factor VIII with Fc fusion protein (rFVIII-Fc) developed by AryoGen Pharmed Company compared to the reference product, Elocta® by Sobi Co., in severe haemophilia A patients. Fc-fused recombinant factor VIII represents a significant advancement in haemophilia A treatment, offering extended half-life and reduced infusion frequency, thus improving patients’ adherence to treatment and quality of life. In a randomized, double-blind, single-dose crossover trial, 50 Iranian patients were assigned to treatment groups in a 1:1 ratio. Subjects received both the test and the reference product with a 7-day washout period between treatments. Pharmacokinetic assessments were conducted over five days post-administration to evaluate the primary outcome, the dose-normalized area under the curve (DNAUC). The results established bioequivalence between rFVIII-Fc (AryoGen Pharmed Company) and Elocta®, based on the DNAUC as the primary outcome, in which 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%. Secondary outcomes, including area under the curve (AUCinf), maximum concentration (Cmax), and half-life, further supported bioequivalence. Safety profiles were comparable, with adverse events mainly related to haemophilia A rather than the intervention. In conclusion, the rFVIII-Fc product is bioequivalent to Elocta® with a similar safety profile, offering an effective alternative for severe haemophilia A patients. This trial was registered in ClinicalTrials.gov (NCT06137092). © The Author(s) 2025.

Style	Citing Format
MLA	Eghbali A, et al.. "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® (Reference Product) in Previously Treated Patients With Severe Haemophilia A." Annals of Hematology, vol. 104, no. 2, 2025, pp. 1195-1202.
APA	Eghbali A, Eshghi P, Toogeh G, Alavi S, Badiei Z, Ghanavat M, Bordbar M, Bazrafshan A, Karimi K, Ahmadinejad M, Sabzvari A, Kafi H (2025). 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® (Reference Product) in Previously Treated Patients With Severe Haemophilia A. Annals of Hematology, 104(2), 1195-1202.
Chicago	Eghbali A, Eshghi P, Toogeh G, Alavi S, Badiei Z, Ghanavat M, Bordbar M, et al.. "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® (Reference Product) in Previously Treated Patients With Severe Haemophilia A." Annals of Hematology 104, no. 2 (2025): 1195-1202.
Harvard	Eghbali A et al. (2025) '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® (Reference Product) in Previously Treated Patients With Severe Haemophilia A', Annals of Hematology, 104(2), pp. 1195-1202.
Vancouver	Eghbali A, Eshghi P, Toogeh G, Alavi S, Badiei Z, Ghanavat M, et al.. 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® (Reference Product) in Previously Treated Patients With Severe Haemophilia A. Annals of Hematology. 2025;104(2):1195-1202.
BibTex	@article{ author = {Eghbali A and Eshghi P and Toogeh G and Alavi S and Badiei Z and Ghanavat M and Bordbar M and Bazrafshan A and Karimi K and Ahmadinejad M and Sabzvari A and Kafi H}, title = {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® (Reference Product) in Previously Treated Patients With Severe Haemophilia A}, journal = {Annals of Hematology}, volume = {104}, number = {2}, pages = {1195-1202}, year = {2025} }
RIS	TY - JOUR AU - Eghbali A AU - Eshghi P AU - Toogeh G AU - Alavi S AU - Badiei Z AU - Ghanavat M AU - Bordbar M AU - Bazrafshan A AU - Karimi K AU - Ahmadinejad M AU - Sabzvari A AU - Kafi H TI - 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® (Reference Product) in Previously Treated Patients With Severe Haemophilia A JO - Annals of Hematology VL - 104 IS - 2 SP - 1195 EP - 1202 PY - 2025 ER -

Style

Citing Format

MLA

Eghbali A, et al.. "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® (Reference Product) in Previously Treated Patients With Severe Haemophilia A." Annals of Hematology, vol. 104, no. 2, 2025, pp. 1195-1202.

APA

Eghbali A, Eshghi P, Toogeh G, Alavi S, Badiei Z, Ghanavat M, Bordbar M, Bazrafshan A, Karimi K, Ahmadinejad M, Sabzvari A, Kafi H (2025). 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® (Reference Product) in Previously Treated Patients With Severe Haemophilia A. Annals of Hematology, 104(2), 1195-1202.

Chicago

Eghbali A, Eshghi P, Toogeh G, Alavi S, Badiei Z, Ghanavat M, Bordbar M, et al.. "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® (Reference Product) in Previously Treated Patients With Severe Haemophilia A." Annals of Hematology 104, no. 2 (2025): 1195-1202.

Harvard

Eghbali A et al. (2025) '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® (Reference Product) in Previously Treated Patients With Severe Haemophilia A', Annals of Hematology, 104(2), pp. 1195-1202.

Vancouver

Eghbali A, Eshghi P, Toogeh G, Alavi S, Badiei Z, Ghanavat M, et al.. 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® (Reference Product) in Previously Treated Patients With Severe Haemophilia A. Annals of Hematology. 2025;104(2):1195-1202.

BibTex

@article{ author = {Eghbali A and Eshghi P and Toogeh G and Alavi S and Badiei Z and Ghanavat M and Bordbar M and Bazrafshan A and Karimi K and Ahmadinejad M and Sabzvari A and Kafi H}, title = {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® (Reference Product) in Previously Treated Patients With Severe Haemophilia A}, journal = {Annals of Hematology}, volume = {104}, number = {2}, pages = {1195-1202}, year = {2025} }

RIS

TY - JOUR
AU - Eghbali A
AU - Eshghi P
AU - Toogeh G
AU - Alavi S
AU - Badiei Z
AU - Ghanavat M
AU - Bordbar M
AU - Bazrafshan A
AU - Karimi K
AU - Ahmadinejad M
AU - Sabzvari A
AU - Kafi H
TI - 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® (Reference Product) in Previously Treated Patients With Severe Haemophilia A
JO - Annals of Hematology
VL - 104
IS - 2
SP - 1195
EP - 1202
PY - 2025
ER -

Science Communicator Platform

Authors

Authors Affiliations

Abstract