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Can a newer clotting factor keep its effectiveness in hemophilia a?

NCT ID NCT07791836

Knowledge-focused Sponsor: AryoGen Pharmed Co. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 28, 2026 · Last updated Aug 28, 2026

Summary

This study looks at hemophilia A patients who have used Coageight, a recombinant factor VIII treatment, to see how many develop inhibitors, which are antibodies that block the treatment's effect. Researchers will test blood samples from about 262 male patients aged 2 and older who have had at least 10 exposure days to Coageight in the past year. The goal is to measure the prevalence of inhibitors using a Bethesda test, providing a clearer picture of the drug's immune profile in real-world use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
efmoroctocog alfa (recombinant factor VIII with Fc fusion, brand name Coageight)
What this could lead to
If the study shows low inhibitor rates, it could support Coageight as a safe long-term option for hemophilia A patients, potentially guiding treatment choices.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by patient selection or prior treatments, and the sample may not represent all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 262 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

A total of 262 Iranian patients diagnosed with hemophilia A and treated with Coageight® (rFVIII-Fc fused, AryoGen Pharmed Co.)

Ages

2 years and older

Sex

Male participants only

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

hemophilia hemophilia A

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemophilia Hemophilia A

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    6 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Imam Khomeini Hospital

    Tehran, Tehran Province, 1419733141, Iran

    Contact Email: •••••@•••••

  • Mofid Children's Hospital

    Tehran, Tehran Province, 1551415468, Iran

  • Seyyed al-Shohada Hospital

    Isfahan, Isfahan, 8184917354, Iran

  • Shahid Ayatollah Dastgheib Hospital

    Shiraz, Shiraz, 7145683769, Iran

  • Shahid Baqaei 2 Hospital

    Ahvāz, Ahvaz, 6138933333, Iran

  • Soroor Clinic

    Mashhad, Mashhad, 9139963185, Iran

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