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ClinicalTrials.gov ID

NCT07791836

Lead Sponsor

AryoGen Pharmed Co.INDUSTRY

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

262Estimated

Last Update Posted

Aug 28, 2026Actual

Start Date

Aug 23, 2026Estimated

Primary Completion Date

Feb 20, 2027Estimated

Completion Date

Feb 20, 2027Estimated

Official Title

A Cross-sectional, Observational, Multi-center Study to Assess the Prevalence of Inhibitor Development in Hemophilia A Patients Receiving Coageight (rFVIII-Fc, Manufactured by AryoGen Pharmed Co.)

Brief Summary

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.).

Detailed Description

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.). To gather the data during the predefined visit of the study, a booklet will be filled by the designated physician. The primary objective of this study is to evaluate the immunogenicity profile of Coageight by assessing the prevalence of factor VIII inhibitors in the study population, as determined by a positive Bethesda assay. The sample size of the study is set at 262 patients.

• Hemophilia A
• Hemophilia

• efmoroctocog alfa

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Male

Accepts Healthy Volunteers

No data available

Eligibility Criteria

Inclusion Criteria:

1. Male patients aged 2 years or older with a signed informed consent by them or their legal guardian
2. Hemophilia A patients with ≥ 50 exposure days to any FVIII product, based on the patient's medical record and the physician's opinion
3. History of receiving at least 10 exposure days with Coageight during the past 12 months, based on the patient's medical records and the physician's opinion

Exclusion Criteria:

1. History of any other coagulation disorders except hemophilia A and disorders related to immune system deficiencies (except for the patients who have undergone Immune Tolerance Induction (ITI) treatment due to inhibitor formation)
2. Patients with hepatitis B or C (based on the patient's medical records), due to potential interference with the inhibitor assessments
3. Participation or intent to participate in another research study during this study period
4. Inability or unwillingness of the patient to meet the protocol requirements, as determined by the physician (e.g., physical or psychological issues)

Observational Model

Cohort

Time Perspective

Cross-Sectional

Lead Sponsor

AryoGen Pharmed Co.INDUSTRY

omid@mui.ac.ir0098 31 3235 0210

Sheikh.hos@mums.ac.ir0098 51 3364 5013