]>
IRCT20150303021315N31 IRCT 2023-05-04 AryoGen Company 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 FAC A randomized, two-armed, double-blind, single-dose, crossover, two sequence, active-controlled, multi-center, 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 rFVIII-Fc (Elocta®, produced by Sobi Company) in previously treated patients with severe hemophilia A 2023-07-26 anticipated 50 Complete https://irct.ir/trial/69777 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Other design features: Single-dose- two sequence, Randomization description: The randomization plan of the patients will be carried out centrally using an R-CRAN software version 4.0.3 with the size 2 or 4 blocks. for a total of 50 patients, randomization scheme will be implemented crosses-over with sequence AB or BA. Once the randomization has been made, each patient is given a code with which he will be identified throughout the study. The assigned code will be made up of 3 numbers (corresponding to the randomization number) and by 4 initials (corresponding to the 2 first letters of the first name, the 2 first letters of the first surname), and 3 numbers (center code), for example ABCD001FAC-001. The randomization number will be assigned in a consecutive way, Blinding description: In this double-blind study, subjects and the product administrators are blinded. The size of vials is different. For this purpose, subjects and administrator of the drug will be blinded by considering two nurses in each center: one nurse who opens the drug package and prepares the drug for injection, and another nurse who injects the drugs and will remain blind throughout the study. Bioequivalence Severe hemophilia A. Intervention 1: Intervention group: rFVIII-Fc (Aryogen Pharmed Co.), IV, 50 units/kg, Single dose, then rFVIII-Fc (Elocta®, Sobi Co.), Cross-over. Intervention 2: Intervention group: rFVIII-Fc (Elocta®, Sobi Co.), IV, 50 units/kg, Single dose, then rFVIII-Fc (Aryogen Pharmed Co.), Cross-over. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No There is no further information
public Dr. Nasim Anjidani
Tehran Province, Tehran, District 3, Attar St, No. 42
Tehran Iran (Islamic Republic of) 1994766411 +98 21 4347 3000 anjidani.n@orchidpharmed.com Orchid Pharmed Co. scientific Dr Aziz Eghbali
Ali-Asghar Children’s Hospital, Shahid Vahid Dastgerdi Street, Moddares Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 19198 16766 +98 21 2222 2045 aziz_eghbali@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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×ULN 12 years no limit Male 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) Z14.02 Symptomatic hemophilia A carrier Treatment - Drugs Treatment - Drugs Intervention group: rFVIII-Fc (Aryogen Pharmed Co.), IV, 50 units/kg, Single dose, then rFVIII-Fc (Elocta®, Sobi Co.), Cross-over Intervention group: rFVIII-Fc (Elocta®, Sobi Co.), IV, 50 units/kg, Single dose, then rFVIII-Fc (Aryogen Pharmed Co.), Cross-over 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). AUC inf. Timepoint: pre-dose and 0.25, 0.5, 1, 3, 6, 8, 24, 48, 72, 96 and 120 h after each infusion. Method of measurement: One-Stage Assay (OSA) and Chromogenic Substrate Assay (CSA). Cmax. Timepoint: pre-dose and 0.25, 0.5, 1, 3, 6, 8, 24, 48, 72, 96 and 120 h after each infusion. Method of measurement: One-Stage Assay (OSA) and Chromogenic Substrate Assay (CSA). Incremental recovery (IR). Timepoint: pre-dose and 0.25, 0.5, 1, 3, 6, 8, 24, 48, 72, 96 and 120 h after each infusion. Method of measurement: One-Stage Assay (OSA) and Chromogenic Substrate Assay (CSA). Half-life (T ½). Timepoint: pre-dose and 0.25, 0.5, 1, 3, 6, 8, 24, 48, 72, 96 and 120 h after each infusion. Method of measurement: One-Stage Assay (OSA) and Chromogenic Substrate Assay (CSA). Vd. Timepoint: pre-dose and 0.25, 0.5, 1, 3, 6, 8, 24, 48, 72, 96 and 120 h after each infusion. Method of measurement: One-Stage Assay (OSA) and Chromogenic Substrate Assay (CSA). Clearance. Timepoint: pre-dose and 0.25, 0.5, 1, 3, 6, 8, 24, 48, 72, 96 and 120 h after each infusion. Method of measurement: One-Stage Assay (OSA) and Chromogenic Substrate Assay (CSA). Assessment of Adverse events. Timepoint: At screening and on days 0,1, 2, 3, 4, 5, 7, 8, 9, 10, 11, 12 and 28. Method of measurement: Clinical monitoring. Immunogenicity: Anti-drug antibody. Timepoint: At screening and on days 7, 12 and 28. Method of measurement: Nijmegen Bethesda assay. AryoGen Company Approved 2023-04-19 Research ethics committees of Iran university of medical sciences Iran University of Medical Sciences Shahid Hemmat Highway Tehran 14496-14535, IRAN Tehran Tehran Iran (Islamic Republic of)