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Jivi under the microscope: new study tracks safety in korean hemophilia patients

NCT ID NCT06222697

Knowledge-focused Sponsor: Bayer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study monitors the safety of Jivi (damoctocog alfa pegol) in 20 Korean patients with hemophilia A who have used other treatments before. Researchers will collect data from routine clinic visits over about 8 months per participant, looking for any medical problems. No extra tests or visits are required, as this is an observational study of 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
damoctocog alfa pegol (Jivi)
What this could lead to
If this study succeeds, it could confirm that Jivi is safe and effective for Korean patients with hemophilia A in real-world settings.
What could go wrong
This is a small, observational study with only 20 participants, so results may not apply to everyone. It does not test new uses or compare Jivi to other treatments.

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 20 people

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

Started

Jan 2024

Expected to finish

Mar 2028

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

The study should be conduct on hemophilia A patients who are prescribed with Jivi (damoctocog alfa pegol) as sole treatment for an approved indication (the treatment and prophylaxis of bleeding in PTPs aged ≥ 12 years with hemophilia A (congenital FVIII deficiency)) by the Ministry of Food and Drug Safety (MFDS) in Korea.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * ≥12 years of age with hemophilia A * Previously treated with FVIII concentrate(s) (plasma derived or recombinant) * Patients who have been treated with Jivi (damoctocog alfa pegol) and those for whom the decision to initiate treatment with Jivi was made as per physician's routine treatment practice with any kind of treatment modality (on-demand, prophylaxis, etc.) * Written informed consent from subject or legal representative; assent from subject when appropriate Exclusion Criteria: * Contraindication according to the local authorized indication (including known hypersensitivity to the drug substance or any of its components (e.g., mouse or hamster protein)) * Patients participating in an investigational program with interventions outside of routine clinical practice * Patients with any other diagnosis of bleeding/coagulation disorder other than hemophilia A * Patients on immune tolerance induction treatment at the time of enrollment

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Conditions

The condition(s) this trial relates to.

hemophilia A hemorrhagic disease

As listed by the trial registrant

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

Hemophilia A Prophylaxis of bleeding Treatment of bleeding

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • Many Locations

    RECRUITING

    Multiple Locations, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.