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Real-World study to track Jivi's bleeding prevention in kids

NCT ID NCT07088458

Disease control Sponsor: Bayer 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This observational study will follow 40 children aged 7 to 12 with hemophilia A who are already prescribed damoctocog alfa pegol (Jivi) to prevent bleeding. Researchers will collect data from routine care, including bleeding episodes and treatment patterns, over two years. The goal is to understand how well the drug works in everyday medical practice.

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 successful, this study could provide real-world evidence on how well Jivi prevents bleeding episodes in children, helping doctors tailor treatment.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by factors like patient selection. It does not test a new drug or compare 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 40 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Mar 2030

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

Patients are to be enrolled from treatment centers specializing in the treatment of bleeding disorders in countries with market authorization for the use of damoctocog alfa pegol for patients aged \>7 years.

Ages

7 to 12 years

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: * Diagnosis of hemophilia A * Patients must be 7 to \< 12 years of age at enrollment * Patients previously treated for hemophilia A ((≥50 exposure days to FVIII) * No current evidence of FVIII inhibitor or clinical suspicion of FVIII inhibitor * Patients without a previous history of inhibitors or patients with a previous history of inhibitors on standard prophylaxis therapy for at least 1 year prior to study entry * Initiation of prescription or currently prescribed damoctocog alfa pegol for regular continuous prophylaxis (intent to treat for 52 weeks/year) * Signed informed consent/assent. Exclusion Criteria: * Presence of a FVIII inhibitor * Concurrent participation in an investigational program with interventions outside of routine clinical practice * Diagnosis of any other bleeding/coagulation disorder other than hemophilia A * Use of another hemostatic agent as the primary method of bleeding prophylaxis during the observation period * Contra-indications according to the local marketing authorization * Current immune tolerance induction (ITI) treatment for a FVIII inhibitor

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Conditions

The condition(s) this trial relates to.

hemophilia A

As listed by the trial registrant

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

Hemophilia A

How to take part

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

  1. 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 ↗

  2. 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.

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