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Completed

NCT Number: NCT06137092

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

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)

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Key information

Conditions

Severe Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders

Age range

12 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Seyed-Al-Shohada Hospital, Isfahan, Iran

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Hb ≥ 8 mg/dL
  • eGFR ≥ 30 mL/min
  • ALT or AST ≤ 5×ULN
  • Serum bilirubin ≤ 1.5×ULN

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 FVIII 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)

Treatment and study plan

Factor VIII, recombinant human with Fc fusion (rFVIII-Fc)

Drug

rFVIII-Fc, IV, 50 units/kg/ single dose, cross-over

Primary outcomes

  1. dose-normalized Area Under the Curve (dnAUC last)

    Time frame: pre-dose, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 8 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours post-dose

    Area under the concentration-time curve measured from the time of administration to the last measurable time point

Secondary outcomes

  1. Area Under the Curve to Infinity (AUC inf)

    Time frame: pre-dose, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 8 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours post-dose

    Area under the concentration-time curve measured from the time of administration to the infinity.

  2. Maximum Plasma Activity (Cmax)

    Time frame: pre-dose, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 8 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours post-dose

    Maximum plasma activity during a dosing interval

  3. Incremental Recovery (IR)

    Time frame: pre-dose, 15 minutes, 30 minutes, 1 hour

    The rise in FVIII activity in IU/dL per unit dose administered in IU/kg

  4. Half-life (T ½)

    Time frame: pre-dose, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 8 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours post-dose

    Time required for the activity of the drug to reach half of its original value

  5. Volume of distribution (Vd)

    Time frame: pre-dose, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 8 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours post-dose

    Volume of distribution estimated from the terminal phase

  6. Clearance (Cl)

    Time frame: pre-dose, 15 minutes, 30 minutes, 1 hour, 3 hours, 6 hours, 8 hours, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours post-dose

    Rate at which the body removes the drug, measured as the volume of the plasma cleared of drug per unit time per unit weight

  7. Safety assessment by evaluation of adverse events (AEs) and abnormal laboratory results

    Time frame: Adverse events collection and documentation was done during the study (up to 28 days)

    Safety assessment, including the incidence of all reported AEs and abnormal laboratory results was done. All AEs were classified based on the Medical Dictionary for Regulatory Activities (MedDRA Desktop Browser 4.0 Beta) terms as System Organ Class (SOC) and Preferred Term (PT). All the reported events were graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). Moreover, seriousness of AEs was assessed according to International Council for Harmonization (ICH-E2B) guidelines. The causality relation was assessed based on the World Health Organization (WHO) criteria.

  8. Immunogenicity assessment

    Time frame: Immunogenicity sampling was done at screening visit and day 7, 12 and 28

    Immunogenicity of factor viii was evaluated at scheduled visits by blood sampling to determine the production of inhibitor against factor viii.

Sponsors and collaborators

Lead sponsor

AryoGen Pharmed Co.

Industry

Registry information

Official study title

A Randomized, Two-armed, Double-blind, Single-dose, Crossover, Two-sequence, Bioequivalence Clinical Trial to Compare PK Parameters and Safety of rFVIII-Fc (AryoGen Pharmed Co.) Versus Elocta® in PTPs With Severe Hemophilia A

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Nov 18, 2023
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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