Bioequivalence clinical trial to compare PK parameters and safety of Factor VIII, recombinant human with Fc fusion (rFVIII-Fc) (Coageight, produced by AryoGen Pharmed Company) versus Elocta® in previously treated patients with severe hemophilia A

Not Applicable

• Conditions: Severe hemophilia A.; Symptomatic hemophilia A carrier; Z14.02

• Registration Number: IRCT20150303021315N31
• Lead Sponsor: AryoGen Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

Male patients = 12 years, with signed informed consent by the patient, or the patient's legally authorized representative for patients under the legal age
Diagnosed with severe hemophilia A (endogenous FVIII <1% [1 IU/dL])
History of at least 150 documented prior exposure days to any FVIII product
Having adequate bone marrow and organ function:•Plt = 80,000 cells/µL •Hgb = 8 mg/dL•eGFR = 30 mL/min•ALT or AST = 5×ULN•Serum bilirubin = 1.5×

Exclusion Criteria

Measurable anti-drug antibody activity against FVIII (= 0.6 BU/mL) at screening or a history of developing anti FVIII antibody
History of other coagulation disorders except for hemophilia A
Acute hemorrhagic state
Infection with HCV or HBV
HIV-positive patients
Infusion of any products containing FVIII within 7 days prior to first administration
Previous treatment with commercially available extended half-life products
Receiving drugs which increase bleeding tendency (e.g: Anti-coagulants, antiplatelets, omega 3, Vit E, etc.) within 2 weeks of screening. NSAIDs are permitted.
Current systemic treatment with immunosuppressive drugs
Hypersensitivity or anaphylaxis associated with any FVIII concentrate or intravenous immunoglobulin (IVIg)
Planned elective surgery
Current enrolment or willing to enroll in any other experimental study during the time of current trial
Subjects assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol (e.g.: physical, psychological and mental problems)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DnAUC last (dose-normalized area under the curve). Timepoint: 12 days after the first intervention. Method of measurement: One-Stage Assay (OSA) and Chromogenic Substrate Assay (CSA).