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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-22

Study Completion Date

2023-09-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pharmacokinetics of rFVIIIFc at Two Vial Strengths

NCT02083965

Severe Hemophilia A

COMPLETED PHASE1

Trial to Evaluate the Efficacy and Safety of a New Full Length Recombinant Human FVIII for Hemophilia A

NCT01029340

Blood Coagulation Disorders Hemophilia A

COMPLETED PHASE3

Study of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Subjects With Severe Hemophilia A

NCT01027377

Severe Hemophilia A

COMPLETED PHASE1

A Study to Evaluate the Pharmacokinetics of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection

NCT03747653

Hemophilia A

UNKNOWN

Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of a Recombinant FVIII in Patients With Severe Hemophilia A

NCT00989196

Hemophilia A

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Severe Hemophilia A

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AryoGen Pharmed Co. rFVIII-Fc/Elocta® (Sobi Co. rFVIII-Fc)

AryoGen Pharmed Co. rFVIII-Fc, IV, 50 units/kg, single dose, then Elocta® (Sobi Co. rFVIII-Fc), IV, 50 units/kg, single dose (cross-over)

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Elocta® (Sobi Co. rFVIII-Fc)/AryoGen Pharmed Co. rFVIII-Fc

Elocta® (Sobi Co. rFVIII-Fc), IV, 50 units/kg, single dose, then AryoGen Pharmed Co. rFVIII-Fc, IV, 50 units/kg, single dose (cross-over)

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No