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NCT07791836Not yet recruiting

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

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.)

Source: ClinicalTrials.gov · Last updated 28 Aug 2026

Brief summary (registry, in English)

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.).

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
262 (estimated)
First submitted
29 Jun 2026
Start date
23 Aug 2026
Primary completion date
20 Feb 2027
Lead sponsor
AryoGen Pharmed Co.
Diseases
Haemophilia
NCT number
NCT07791836

What you commit to

  • Study type: Observational
  • Planned participants: 262
  • From 23 Aug 2026 to the primary completion date, 20 Feb 2027
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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)
  • Patients with hepatitis B or C (based on the patient's medical records), due to potential interference with the inhibitor assessments

Other

  • Participation or intent to participate in another research study during this study period
  • Inability or unwillingness of the patient to meet the protocol requirements, as determined by the physician (e.g., physical or psychological issues)

Who the study is looking for

  • Male patients aged 2 years or older with a signed informed consent by them or their legal guardian
  • Hemophilia A patients with ≥ 50 exposure days to any FVIII product, based on the patient's medical record and the physician's opinion
  • 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

Age in the registry: 2 years to - · Sex: Male

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shahid Baqaei 2 Hospital
Coordinator of this site? Confirm its status
AhvāzIranUnknown status
Seyyed al-Shohada Hospital
Coordinator of this site? Confirm its status
IsfahanIranUnknown status
Soroor Clinic
Coordinator of this site? Confirm its status
MashhadIranUnknown status
Shahid Ayatollah Dastgheib Hospital
Coordinator of this site? Confirm its status
ShirazIranUnknown status
Mofid Children's Hospital
Coordinator of this site? Confirm its status
TehranIranUnknown status
Imam Khomeini Hospital
Coordinator of this site? Confirm its status
TehranIranUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.