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4-year watch on Jivi's safety for hemophilia a patients

NCT ID NCT04461639

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Updated 2 times

Summary

This study follows 62 people with hemophilia A who are already using Jivi (a long-acting clotting factor) to prevent bleeding. Researchers will track safety events like side effects and lab changes over at least 4 years during routine doctor visits. The goal is to better understand the long-term safety of this medication in real-world use.

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

62 people

The number who actually took part.

Started

May 2021

Expected to finish

Jun 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

All previously treated patients (PTPs) with hemophilia A receiving prophylaxis with damoctocog alfa pegol will be eligible to be enrolled in the study. Indications and contra-indications according to the local market authorization will be carefully considered

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: * Signed informed consent/assent will be obtained before any study-related activities * PTPs with hemophilia A assigned to Jivi prophylaxis treatment * Negative FVIII inhibitor test before study entry * Decision to initiate treatment with commercially available Jivi has been made by the treating physician before and independently from the decision to include the patient in this study Exclusion Criteria: * Known or suspected contraindications to Jivi or related products * Mental incapacity, unwillingness or other barriers precluding adequate understanding or cooperation * Participation in an investigational program with interventions outside of routine clinical practice

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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

Contacts and locations

Locations

  • Many Locations

    Multiple Locations, Austria

  • Many Locations

    Multiple Locations, Germany

  • Many Locations

    Multiple Locations, Greece

  • Many Locations

    Multiple Locations, Italy

  • Many Locations

    Multiple Locations, Slovenia

  • Many Locations

    Multiple Locations, Spain

More trials for these conditions

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