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New hope for young hemophilia patients: jivi safety trial shows promise for fewer injections

NCT ID NCT05147662

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 1 time

Summary

This study tested the safety of Jivi (BAY 94-9027), a longer-lasting clotting factor, in 36 children aged 7 to 12 with severe hemophilia A. The medicine is already approved for older patients, but this trial focused on younger kids to check for allergic reactions and whether the drug stops working well. Participants received injections twice a week for 6 months, then could switch to a schedule with up to 5 days between doses, and were monitored for 2 years.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

36 people

The number who actually took part.

Started

Mar 2022

Finished

Jun 2025

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.

Ages

7 to 11 years

Sex

Male participants only

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: * Participants with severe hemophilia A (participant's own FVIII activity \[FVIII:C\] \<1%) * Participants must be previously treated with FVIII concentrate(s) (plasma derived or recombinant) for a minimum of 50 exposure days (EDs) at the time of signing the informed consent * Participant has understood the study if appropriate for his age, informed consent must be signed by the parent, the participant can only sign the assent * Willingness and ability of participants and/or parents /caregivers to complete training in the use of the electronic patient diary (EPD) and to document infusions during the study Exclusion Criteria: * History of FVIII inhibitors * Current evidence of inhibitor to FVIII measured using the Nijmegen-modified Bethesda assay (≥0.6 BU/mL) at the time of screening (central laboratory) * Any other inherited or acquired bleeding disorder in addition to hemophilia A (e.g. von Willebrand disease, hemophilia B) * Known hypersensitivity or allergic reaction to drug substance, excipients or mouse or hamster protein * Any other significant medical condition that the investigator feels would be a risk to the patient or would impede the study * Requires any pre-medication to tolerate FVIII treatment (e.g. antihistamines) * Planned major surgery during the study * Any individual who is receiving chemotherapy, immune modulatory drugs other than anti-retroviral chemotherapy, or chronic use of oral or intravenous (IV) corticosteroids (\> 14 days) within the last 3 months * Any individual who received commercially available subcutaneous factor substitution therapy (emicizumab) within the last 6 months * The participant is currently participating in another investigational drug study or has participated in a clinical study involving an investigational drug within 30 days of study entry or previous participation in a clinical study with BAY94-9027

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Conditions

The condition(s) this trial relates to.

hemophilia A hemorrhagic disease severe hemophilia A

As listed by the trial registrant

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

Children Hemophilia A Prophylaxis of bleeding Treatment of bleeding

Contacts and locations

Locations

  • Acibadem Adana Hastanesi, Çocuk Sagligi ve Hastaliklari, Çocuk Hematoloji-Onkoloji Bölümü

    Adana, 01130, Turkey (Türkiye)

  • Akdeniz Üniversitesi Tip Fakültesi Çocuk Sagligi ve Hastaliklari Anabilim Dali Çocuk Hematoloji ve Onkoloji Bilim Dali

    Antalya, 07059, Turkey (Türkiye)

  • Alberta Children's Hospital | Hematology / Oncology / Blood and Marrow Transplant Clinic

    Calgary, Alberta, T3B 6A8, Canada

  • Arnold Palmer Hospital for Children

    Orlando, Florida, 32806, United States

  • Ege Üniversitesi Tip Fakültesi, Çocuk Sagligi ve Hastaliklari Anabilim Dali, Çocuk Hematoloji Bilim Dali

    Izmir, 35100, Turkey (Türkiye)

  • Gaziantep Üniversitesi Tip Fakültesi, Sahinbey Arastirma Ve Uygulama Hastanesi, Çocuk Hematoloji ve Onkoloji Bilim Dali

    Gaziantep, 27100, Turkey (Türkiye)

  • HEMORIO

    Rio de Janeiro, Rio de Janeiro, 20211-030, Brazil

  • Hacettepe Üniversitesi Tip Fakültesi, Hacettepe Ihsan Dogramaci Çocuk Hastanesi,

    Ankara, 06230, Turkey (Türkiye)

  • Hosp Clínicas Facult. Med. de Ribeirão Preto / USP

    Ribeirão Preto, São Paulo, 14051-140, Brazil

  • Hospital das Clínicas de Campinas - UNICAMP

    Uberlândia, Minas Gerais, 13083-878, Brazil

  • Hospital de Niños Sor María Ludovica

    La Plata, Buenos Aires, 1900, Argentina

  • Instituo Hematología Arbesú

    Godoy Cruz, Mendoza Province, 5501, Argentina

  • Instituto de Hematología Dr. Rubén Dávoli

    Rosario, Santa Fe Province, S2000CKF, Argentina

  • Irmandadade da Santa Casa de Misericordia de Sao Paulo (iSANTACASA)

    São Paulo, São Paulo, 01223-001, Brazil

  • McMaster University Medical Centre | McMaster Children's Hospital | Hematology

    Hamilton, Ontario, L8N 3Z5, Canada

  • OUS Rikshospitalet Klinisk Forskningspost Barn

    Oslo, Oslo, 0372, Norway

  • Ondokuz Mayis Üniversitesi Tip Fakültesi, Saglik Uygulama ve Arastirma Merkezi, Çocuk Sagligi ve Hastaliklari Anabilim Dali

    Samsun, 55200, Turkey (Türkiye)

  • Ospedale Pediatrico Bambino Gesù - Oncoematologia, Trapianto Emopoietico e Terapie Cellulari

    Roma (RM), Lazio, 00165, Italy

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