Prevalence of Inhibitor Development in Hemophilia A Patients Receiving Coageight: A Multicenter Cross-sectional Observational Study

Sponsor
AryoGen Pharmed Co.
Study ID
NCT07791836
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
2 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • efmoroctocog alfa — DRUG
    This study assesses patients with a history of at least 10 exposure days (EDs) to recombinant factor VIII with Fc fusion (Coageight) within the 12 months prior to enrollment.

Study Details

This is a cross-sectional, observational, multi-center study to assess the prevalence of inhibitor development in hemophilia A patients receiving Coageight (rFVIII-Fc, AryoGen Pharmed Co.).

Key Dates

First listed
Aug 28, 2026
Start date
Aug 23, 2026
Status verified
Jun 2026
Primary completion
Feb 20, 2027
Completion
Feb 20, 2027

Study Design

Enrollment
262 participants (estimated)

Arms

  • Arm: Patients receiving Coageight (rFVIII-Fc, AryoGen Pharmed Co.)

Primary Outcome Measure

Evaluation of the immunogenicity profile of the Coageight (rFVIII-Fc, manufactured by AryoGen Pharmed Co.) [ Time Frame: Day 0 (-7 to 0 days) ]

Central Contacts

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