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

N/ANot Yet RecruitingNCT07791836

AryoGen Pharmed Co.262 enrolled

Overview

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.).

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.

Study Type

OBSERVATIONAL

Enrollment

262

Conditions

Hemophilia A Hemophilia

Interventions

efmoroctocog alfaDRUG

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.

Eligibility

Sex: MALEMin age: 2 Years

Medical Language ↔ Plain English

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)

Locations (6)

Shahid Baqaei 2 Hospital

Ahvāz, Ahvaz, Iran

Seyyed al-Shohada Hospital

Isfahan, Isfahan, Iran

Soroor Clinic

Mashhad, Mashhad, Iran

Shahid Ayatollah Dastgheib Hospital

Shiraz, Shiraz, Iran

Outcomes

Primary Outcomes

Evaluation of the immunogenicity profile of the Coageight (rFVIII-Fc, manufactured by AryoGen Pharmed Co.)

Assessing the prevalence of inhibitors against factor VIII in the study population, as measured by a positive Bethesda test

Time frame: Day 0 (-7 to 0 days)

Central Contacts

Hamidreza Kafi, Clinical Pharmecy Ph.D

CONTACT

00982143473000 Kafi.H@Orchidpharmed.com

Data from ClinicalTrials.gov

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