NCT06137092

Brief 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2023

Shorter than P25 for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 22, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 30, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
Last Updated

November 18, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

October 30, 2023

Last Update Submit

November 13, 2023

Conditions

Severe Hemophilia A

Outcome Measures

Primary Outcomes (1)

  • 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

    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)

    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)

    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)

    pre-dose, 15 minutes, 30 minutes, 1 hour

  • Half-life (T ½)

    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)

    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

  • +3 more secondary outcomes

Study Arms (2)

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)

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)

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

Interventions

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

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

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

Eligibility Criteria

Age12 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly male patients are eligible for the study.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Seyed-Al-Shohada Hospital

Isfahan, Iran

Location

Sarvar Clinic

Mashhad, Iran

Location

Dastqeib Hospital

Shiraz, Iran

Location

Imam Khomeini

Tehran, Iran

Location

Mofid Hospital

Tehran, Iran

Location

Related Publications (1)

  • 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.

    PMID: 39934428DERIVED

MeSH Terms

Conditions

Hemophilia A

Interventions

Factor VIII

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Blood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsProtein PrecursorsBiological Factors

Study Officials

  • Aziz Eghbali, Assoc. Prof.

    Iran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2023

First Posted

November 18, 2023

Study Start

July 22, 2023

Primary Completion

September 27, 2023

Study Completion

September 27, 2023

Last Updated

November 18, 2023

Record last verified: 2023-10

Locations

IR(5)