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New clotting factor shows promise in reducing bleeds for hemophilia a patients

NCT ID NCT04161495

Completed Disease control Sponsor: Bioverativ, a Sanofi company Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 3 study tested a new medicine called BIVV001 (efanesoctocog alfa) in 159 people aged 12 and older with severe hemophilia A. The goal was to see if regular injections could prevent bleeding episodes, improve joint health, and enhance quality of life. Participants received the drug intravenously, and researchers measured how many bleeds occurred per year.

What this could mean

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

Active substance
efanesoctocog alfa (BIVV001)
What this could lead to
If successful, this could provide a more effective and longer-lasting treatment option for people with severe hemophilia A, reducing the frequency of bleeding episodes and improving daily life.
What could go wrong
This is a phase 3 trial, but results may not apply to all patients. There is a risk of side effects like allergic reactions or development of inhibitors that block the treatment's effect.

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

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Conditions

The condition(s) this trial relates to.

hemophilia A severe hemophilia A

As listed by the trial registrant

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

FACTOR VIII DEFICIENCY

Contacts and locations

Locations

  • Investigational Site Number 121

    Perth, Australia

  • Investigational Site Number 122

    Sydney, Australia

  • Investigational Site Number 136

    Buenos Aires, Argentina

  • Investigational Site Number 137

    Buenos Aires, Argentina

  • Investigational Site Number 139

    Mendoza, Argentina

  • Investigational Site Number 161

    Brussels, Belgium

  • Investigational Site Number 171

    Plovdiv, Bulgaria

  • Investigational Site Number 172

    Sofia, Bulgaria

  • Investigational Site Number 181

    Campinas, Brazil

  • Investigational Site Number 202

    Hamilton, Canada

  • Investigational Site Number 205

    Hamilton, Canada

  • Investigational Site Number 281

    Brest, France

  • Investigational Site Number 282

    Lyon, France

  • Investigational Site Number 283

    Lille, France

  • Investigational Site Number 284

    Marseille, France

  • Investigational Site Number 302

    Bonn, Germany

  • Investigational Site Number 303

    Frankfurt, Germany

  • Investigational Site Number 304

    Berlin, Germany

  • Investigational Site Number 312

    Budapest, Hungary

  • Investigational Site Number 314

    Debrecen, Hungary

  • Investigational Site Number 321

    Athens, Greece

  • Investigational Site Number 401

    Vicenza, Italy

  • Investigational Site Number 402

    Milan, Italy

  • Investigational Site Number 421

    Tokyo, Japan

  • Investigational Site Number 422

    Nara, Japan

  • Investigational Site Number 423

    Kitakyushu, Japan

  • Investigational Site Number 424

    Tokyo, Japan

  • Investigational Site Number 425

    Nagoya, Japan

  • Investigational Site Number 426

    Kawasaki, Japan

  • Investigational Site Number 435

    Durango, Mexico

  • Investigational Site Number 521

    Madrid, Spain

  • Investigational Site Number 531

    Chang-hua, Taiwan

  • Investigational Site Number 532

    Taipei, Taiwan

  • Investigational Site Number 581

    Basingstoke, United Kingdom

  • Investigational Site Number 581

    London, United Kingdom

  • Investigational Site Number 600

    Seoul, South Korea

  • Investigational Site Number 601

    Seoul, South Korea

  • Investigational Site Number 603

    Daegu, South Korea

  • Investigational Site Number 641

    Utrecht, Netherlands

  • Investigational Site Number 902

    Seattle, Washington, 98101-3932, United States

  • Investigational Site Number 906

    Las Vegas, Nevada, 89113, United States

  • Investigational Site Number 908

    Lansing, Michigan, 48824, United States

  • Investigational Site Number 911

    San Diego, California, 92121, United States

  • Investigational Site Number 917

    Gainesville, Florida, 32610, United States

  • Investigational Site Number 919

    Ann Arbor, Michigan, 48109, United States

  • Investigational Site Number 920

    Los Angeles, California, 90007-2664, United States

  • Investigational Site Number 921

    Los Angeles, California, 90027, United States

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