Can a new clotting factor offer better bleed protection for severe hemophilia?

NCT ID NCT04644575

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

First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This phase 3 trial is investigating the long-term safety and effectiveness of an experimental clotting factor called BIVV001 in people with severe hemophilia A. The study aims to see if regular infusions of this therapy can prevent bleeding episodes, protect joint health, and improve quality of life. Participants will receive the treatment intravenously and be monitored for side effects, including the development of antibodies that could block the therapy.

What this could mean

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

Active substance: an experimental clotting factor called efanesoctocog alfa (BIVV001)
What this could lead to: If successful, this could offer a more effective and longer-lasting treatment option for people with severe hemophilia A, potentially reducing bleeding episodes and improving joint health.
What could go wrong: This is an early-stage trial focused on safety, so the treatment may not prove effective for everyone. There is a risk of developing antibodies that neutralize the therapy.

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.

HEMOPHILIA A

Contacts and locations

Locations

Bloodworks Northwest Site Number : 8400005

Seattle, Washington, 98104, United States
Children's Healthcare of Atlanta Site Number : 8400016

Atlanta, Georgia, 30322, United States
Children's Hospital Los Angeles Site Number : 8400009

Los Angeles, California, 90027, United States
Children's Hospital Of Iowa Site Number : 8400011

Iowa City, Iowa, 52242, United States
Children's Hospital of Wisconsin Site Number : 8400014

Milwaukee, Wisconsin, 53226-0509, United States
Children's Research Institute Site Number : 8400013

Columbus, Ohio, 43205-2696, United States
Cincinnati Children's Hospital Medical Center Site Number : 8400012

Cincinnati, Ohio, 45229, United States
East Carolina University -2390 Hemby Ln Site Number : 8400015

Greenville, North Carolina, 27834, United States
Hemocentro Campinas - UNICAMP Site Number : 0760001

Campinas, São Paulo, 13083-970, Brazil
Hemostasis and Thrombosis Center of Nevada Site Number : 8400001

Las Vegas, Nevada, 89113, United States
Investigational Site Number : 0320001

CABA, Buenos Aires F.D., C1425BWE, Argentina
Investigational Site Number : 0320002

Godoy Cruz, Mendoza Province, M5504FKD, Argentina
Investigational Site Number : 0320003

Buenos Aires, C1015ABO, Argentina
Investigational Site Number : 0360001

Westmead, New South Wales, 2145, Australia
Investigational Site Number : 0360002

South Brisbane, Queensland, 4101, Australia
Investigational Site Number : 0360003

Murdoch, Western Australia, 6961, Australia
Investigational Site Number : 0360004

Camperdown, New South Wales, 2050, Australia
Investigational Site Number : 0560003

Woluwe-Saint-Lambert, 1200, Belgium
Investigational Site Number : 1000171

Plovdiv, 4002, Bulgaria
Investigational Site Number : 1000172

Sofia, 1756, Bulgaria
Investigational Site Number : 1240001

Toronto, Ontario, M5G 1X8, Canada
Investigational Site Number : 1240002

Ottawa, Ontario, K1H 8L1, Canada
Investigational Site Number : 1240004

Hamilton, Ontario, L8N 3Z5, Canada
Investigational Site Number : 1240005

Hamilton, Ontario, L8L 8E7, Canada
Investigational Site Number : 1560001

Guangzhou, 510515, China
Investigational Site Number : 1560002

Beijing, 100045, China
Investigational Site Number : 1560003

Hangzhou, 310003, China
Investigational Site Number : 1560004

Hangzhou, 310003, China
Investigational Site Number : 1560005

Jinan, 250013, China
Investigational Site Number : 1560006

Beijing, 100730, China
Investigational Site Number : 1560007

Suzhou, 215006, China
Investigational Site Number : 1560009

Kunming, 650032, China
Investigational Site Number : 1560010

Kunming, 650101, China
Investigational Site Number : 1560013

Lanzhou, 730000, China
Investigational Site Number : 1580001

Taichung, 40201, Taiwan
Investigational Site Number : 1580002

Taipei, 10002, Taiwan
Investigational Site Number : 1580003

Taichung, 407, Taiwan
Investigational Site Number : 1580004

Taipei, 11031, Taiwan
Investigational Site Number : 1580005

Changhua County, 500, Taiwan
Investigational Site Number : 2500001

Le Kremlin-Bicêtre, 94275, France
Investigational Site Number : 2500003

Lille, 59037, France
Investigational Site Number : 2500004

Bron, 69500, France
Investigational Site Number : 2500005

Brest, 29200, France
Investigational Site Number : 2500006

Marseille, 13385, France
Investigational Site Number : 2760001

Frankfurt am Main, 60590, Germany
Investigational Site Number : 2760002

München, 80337, Germany
Investigational Site Number : 2760302

Bonn, 53127, Germany
Investigational Site Number : 2760304

Berlin, 10249, Germany
Investigational Site Number : 3000001

Athens, 11527, Greece
Investigational Site Number : 3480002

Budapest, 1134, Hungary
Investigational Site Number : 3480004

Debrecen, 4093, Hungary
Investigational Site Number : 3480005

Pécs, 7623, Hungary
Investigational Site Number : 3720001

Dublin, D12 N512, Ireland
Investigational Site Number : 3800001

Milan, 20121, Italy
Investigational Site Number : 3800002

Naples, Campania, 80123, Italy
Investigational Site Number : 3800003

Vicenza, 36100, Italy
Investigational Site Number : 3920421

Shinjuku-ku, Tokyo, 160-0023, Japan
Investigational Site Number : 3920422

Kashihara-Shi, Niigata, 634-8521, Japan
Investigational Site Number : 3920423

Kitakyushu-shi, Fukuoka, 807-8556, Japan
Investigational Site Number : 3920424

Suginami-ku, Tokyo, 167-0035, Japan
Investigational Site Number : 3920425

Nagoya, Aichi-ken, 466-0065, Japan
Investigational Site Number : 3920426

Kawasaki-shi, Kanagawa, 216-8511, Japan
Investigational Site Number : 4100600

Seoul, Seoul-teukbyeolsi, 05278, South Korea
Investigational Site Number : 4100601

Seoul, Seoul-teukbyeolsi, 03722, South Korea
Investigational Site Number : 4100603

Daegu, Daegu, 41404, South Korea
Investigational Site Number : 5280001

Utrecht, 3584 CX, Netherlands
Investigational Site Number : 5280002

Amsterdam, 1105 AZ, Netherlands
Investigational Site Number : 7240001

Madrid, Madrid, Comunidad de, 28046, Spain
Investigational Site Number : 7240002

Esplugues de Llobregat, Catalunya [Cataluña], 08950, Spain
Investigational Site Number : 7520001

Malmö, 20502, Sweden
Investigational Site Number : 7560001

Zurich, 8032, Switzerland
Investigational Site Number : 7920001

Istanbul, 34390, Turkey (Türkiye)
Investigational Site Number : 7920003

Izmir, TR-35100, Turkey (Türkiye)
Investigational Site Number : 7920004

Antalya, 07059, Turkey (Türkiye)
Investigational Site Number : 8260001

London, London, City of, WC1N 3JH, United Kingdom
Investigational Site Number : 8260003

Birmingham, B4 6NH, United Kingdom
Investigational Site Number : 8260004

Hampshire, RG24 9NA, United Kingdom
Investigational Site Number : 8260005

London, London, City of, NW3 2QG, United Kingdom
Michigan State University School Of Med Site Number : 8400002

East Lansing, Michigan, 48824, United States
New York Presbyterian Hospital/Weill Cornell Medical Center Site Number : 8400017

New York, New York, 10021, United States
Orthopaedic Institute for Children Site Number : 8400003

Los Angeles, California, 90007, United States
Rush University Medical Center Site Number : 8400010

Chicago, Illinois, 60612-3833, United States
University of California San Diego Site Number : 8400007

San Diego, California, 92121, United States
University of Florida Health Site Number : 8400008

Gainesville, Florida, 32608, United States
University of Michigan Medical Center Site Number : 8400006

Ann Arbor, Michigan, 48109, United States

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