Severe Hemophilia APhase 3NCT06137092
rFVIII-Fc (Produced by AryoGen Pharmed Co.) Pharmacokinetic Study
A Phase 3 study testing Factor VIII, recombinant human with Fc fusion (rFVIII-Fc) in people with Severe Hemophilia A, run by AryoGen Pharmed Co. at 5 sites in Iran.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 12 years and older, men only
- Conditions the study is for
- Severe Hemophilia A
- What is being tested?
- Factor VIII, recombinant human with Fc fusion (rFVIII-Fc)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesIran
- Study dates
- 22 Jul 2023to 27 Sep 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- eGFR ≥ 30 mL/min
- ALT or AST ≤ 5×ULN
- Serum bilirubin ≤ 1.5×ULN
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Iran5 sites
Seyed-Al-Shohada Hospital
Isfahan
Sarvar Clinic
Mashhad
Dastqeib Hospital
Shiraz
Imam Khomeini
Tehran
Mofid Hospital
Tehran
About this study
Official 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
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)
- Conditions
- Severe Hemophilia A
- Being tested
- Factor VIII, recombinant human with Fc fusion (rFVIII-Fc)
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Factor VIII, recombinant human with Fc fusion (rFVIII-Fc)Drug
rFVIII-Fc, IV, 50 units/kg/ single dose, cross-over
| Study group | Role | What they receive |
|---|---|---|
| AryoGen Pharmed Co. rFVIII-Fc/Elocta® (Sobi Co. rFVIII-Fc) | Experimental | 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) Receives: Drug: Factor VIII, recombinant human with Fc fusion (rFVIII-Fc) |
| Elocta® (Sobi Co. rFVIII-Fc)/AryoGen Pharmed Co. rFVIII-Fc | Experimental | 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) Receives: Drug: Factor VIII, recombinant human with Fc fusion (rFVIII-Fc) |
What is being measured
The primary outcome is the main question the study is designed to answer.
dose-normalized Area Under the Curve (dnAUC last)
Area under the concentration-time curve measured from the time of administration to the last measurable time point
Measured: 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
Secondary outcomes (8)
Area Under the Curve to Infinity (AUC inf)
Area under the concentration-time curve measured from the time of administration to the infinity.
Measured: 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 (Cmax)
Maximum plasma activity during a dosing interval
Measured: 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
Incremental Recovery (IR)
The rise in FVIII activity in IU/dL per unit dose administered in IU/kg
Measured: pre-dose, 15 minutes, 30 minutes, 1 hour
Half-life (T ½)
Time required for the activity of the drug to reach half of its original value
Measured: 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 (Vd)
Volume of distribution estimated from the terminal phase
Measured: 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
Clearance (Cl)
Rate at which the body removes the drug, measured as the volume of the plasma cleared of drug per unit time per unit weight
Measured: 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
Safety assessment by evaluation of adverse events (AEs) and abnormal laboratory results
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.
Measured: Adverse events collection and documentation was done during the study (up to 28 days)
Immunogenicity assessment
Immunogenicity of factor viii was evaluated at scheduled visits by blood sampling to determine the production of inhibitor against factor viii.
Measured: Immunogenicity sampling was done at screening visit and day 7, 12 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start22 Jul 2023
- Primary completion27 Sep 2023
- Study completion27 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Hemophilia AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- AryoGen Pharmed Co.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aziz Eghbali, Assoc. Prof., Principal investigator, Iran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137092
- Sponsor's protocol ID
- FVIII.ARY.AE.00.PK
- Status last verified
- Oct 2023
- First submitted
- 30 Oct 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Eghbali A, Eshghi P, Toogeh G, Alavi S, Badiei Z, Ghanavat M, Bordbar M, Bazrafshan A, Karimi K, Ahmadinejad M, Sabzvari A, Kafi H. 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(R) (reference product) in previously treated patients with severe haemophilia A. Ann Hematol. 2025 Feb;104(2):1195-1202. doi: 10.1007/s00277-025-06242-z. Epub 2025 Feb 12.
PubMed 39934428
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06137092
- Acronym / sponsor ID
- FVIII.ARY.AE.00.PK
- Conditions
- Severe Hemophilia A
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- AryoGen Pharmed Co.Industry (pharma, biotech, devices)
- Study start
- 22 Jul 2023 (actual)
- Primary completion
- 27 Sep 2023 (actual)
- Study completion
- 27 Sep 2023 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AryoGen Pharmed Co. rFVIII-Fc/Elocta® (Sobi Co. rFVIII-Fc) | Experimental | Drug: Factor VIII, recombinant human with Fc fusion (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) |
| Elocta® (Sobi Co. rFVIII-Fc)/AryoGen Pharmed Co. rFVIII-Fc | Experimental | Drug: Factor VIII, recombinant human with Fc fusion (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) |
Who may qualify
- Ages
- 12 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Factor VIII, recombinant human with Fc fusion (rFVIII-Fc)rFVIII-Fc, IV, 50 units/kg/ single dose, cross-over | Drug | AryoGen Pharmed Co. rFVIII-Fc/Elocta® (Sobi Co. rFVIII-Fc), Elocta® (Sobi Co. rFVIII-Fc)/AryoGen Pharmed Co. rFVIII-Fc |
Primary outcome
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
8 secondary outcomes
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
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
Incremental Recovery (IR)
Time frame: pre-dose, 15 minutes, 30 minutes, 1 hour
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
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
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
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)
Immunogenicity assessment
Time frame: Immunogenicity sampling was done at screening visit and day 7, 12 and 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 39934428Eghbali A, Eshghi P, Toogeh G, Alavi S, Badiei Z, Ghanavat M, Bordbar M, Bazrafshan A, Karimi K, Ahmadinejad M, Sabzvari A, Kafi H. 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(R) (reference product) in previously treated patients with severe haemophilia A. Ann Hematol. 2025 Feb;104(2):1195-1202. doi: 10.1007/s00277-025-06242-z. Epub 2025 Feb 12.
Related trials for Severe Hemophilia A
RecruitingPhase 1/2
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A
Hemophilia A
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
RecruitingPhase 3
Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors
Hemophilia A, Hemophilia B
Active, not recruitingPhase 4
A Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes in Participants With Severe or Moderate Hemophilia A Without Factor VIII Inhibitors on Emicizumab Prophylaxis
Severe Hemophilia A, Moderate Hemophilia A
Not yet recruitingObservational study
Post Approval Phase 4 Study to Learn More About How Safe Octocog Alfa is, and How Well it Works in Patients With Severe Hemophilia A in India
Severe Hemophilia A
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aziz Eghbali, Assoc. Prof. principal investigator
Iran University of Medical Sciences
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Factor VIII, recombinant human with Fc fusion (rFVIII-Fc) in people with Severe Hemophilia A, run by AryoGen Pharmed Co. at 5 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06137092, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.