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New shot could help prevent bleeding in severe hemophilia

NCT ID NCT05145127

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at the long-term safety and effectiveness of a medicine called marstacimab for people with severe hemophilia A or B. Participants receive regular injections to help prevent bleeding episodes. The goal is to see if this treatment is safe and reduces bleeds over time.

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

About 245 people

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

Started

Nov 2021

Expected to finish

Jul 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.

Ages

1 year to 74 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: * All participants will have a minimum body weight as defined by parent studies * Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures. * Participants have successfully completed participation in parent studies, defined as did not require "Early Termination" Exclusion Criteria: * Previous or current treatment for or history of coronary artery disease, venous or arterial thrombosis (CTCAE Grade \>3), or ischemic disease (except catheter-associated thrombosis) * Abnormal renal function as defined by eGFR \<30 mL.min/1.73 m(2) * Known planned surgical procedure during the planned study period * Unstable hepatic function as determined by the Investigator clinical assessment and review of the participant's most recent laboratory results, which would make the participant inappropriate for the study * For participants known to be HIV+, worsening disease status as determined by the Investigator clinical assessment and review of participant's most recent laboratory results, to include recent locally available CD4 count (if available), which would make the participant inappropriate for the study * Regular, concomitant therapy with immunomodulatory drugs (eg, IVIG, and routine systemic corticosteroids, rituximab) * Ongoing or planned use of immune tolerance induction or prophylaxis with FVIII or FIX replacement during the study * Participation in other study involving investigational drug(s) or investigational vaccine(s) within 30 days or 5 half-lives prior to or during study participation, with the exception of participation in parent studies * Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the Investigator, and their respective family members

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Conditions

The condition(s) this trial relates to.

hemophilia A hemophilia B severe hemophilia A

As listed by the trial registrant

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

Hemophilia A Hemophilia B

How to take part

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

  1. The places running it

    69 sites in 23 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • AOU Policlinico Umberto I

    RECRUITING

    Roma, RM, 00161, Italy

  • Aarhus Universitetshospital, Skejby

    RECRUITING

    Aarhus, Central Jutland, 8200, Denmark

  • Acibadem Adana Hospital

    RECRUITING

    Adana, 01130, Turkey (Türkiye)

  • Arbesu Hematología

    RECRUITING

    Mendoza, M5501, Argentina

  • Beijing Children's Hospital, Capital Medical University

    RECRUITING

    Beijing, 100045, China

  • Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatán S.

    RECRUITING

    Mérida, Yucatán, 97130, Mexico

  • ChangHua Christian Hospital

    RECRUITING

    Changhua, Changhua County, 500, Taiwan

  • Charlotte Maxeke Johannesburg Academic Hospital

    ACTIVE_NOT_RECRUITING

    Johannesburg, Gauteng, 2193, South Africa

  • Clinical Center Nis

    RECRUITING

    Niš, 18000, Serbia

  • Clinical Center Nis

    ACTIVE_NOT_RECRUITING

    Niš, 18000, Serbia

  • Detska fakultna nemocnica Kosice

    RECRUITING

    Košice, 040 11, Slovakia

  • Ege University Faculty of Medicine

    RECRUITING

    Izmir, 35040, Turkey (Türkiye)

  • Ege University Faculty of Medicine

    RECRUITING

    Izmir, 35100, Turkey (Türkiye)

  • Erciyes University Faculty of Medicine

    RECRUITING

    Kayseri, 38039, Turkey (Türkiye)

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    RECRUITING

    Milan, 20122, Italy

  • Gazi University Health Research and Application Center Gazi Hospital

    RECRUITING

    Ankara, 06560, Turkey (Türkiye)

  • Gazi University Medical Faculty

    RECRUITING

    Ankara, 06500, Turkey (Türkiye)

  • Gaziantep University Şahinbey Research and Practice Hospital

    RECRUITING

    Gaziantep, 27310, Turkey (Türkiye)

  • Guy's & St Thomas' NHS Foundation Trust

    RECRUITING

    London, London, CITY of, SE1 9RT, United Kingdom

  • Guy's & St Thomas' NHS Foundation Trust, St Thomas' Hospital

    RECRUITING

    London, SE1 7EH, United Kingdom

  • HEMOES

    RECRUITING

    Vitória, Espírito Santo, 29047-105, Brazil

  • Hacettepe University Faculty of Medicine

    RECRUITING

    Ankara, 06100, Turkey (Türkiye)

  • Hacettepe University Medical Faculty Hospital

    RECRUITING

    Ankara, 06230, Turkey (Türkiye)

  • Hamilton Health Sciences - McMaster University Medical Centre

    RECRUITING

    Hamilton, Ontario, L8N 3Z5, Canada

  • Hamilton Health Sciences - McMaster University Medical Centre

    RECRUITING

    Hamilton, Ontario, L8N3Z5, Canada

  • Hiroshima University Hospital

    ACTIVE_NOT_RECRUITING

    Hiroshima, 734-8551, Japan

  • Hospital Universitario A Coruna

    RECRUITING

    A Coruña, 15006, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Miguel Servet

    RECRUITING

    Zaragoza, 50009, Spain

  • Hospital Universitario Vall d´Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hôpital Universitaire Necker Enfants Malades

    RECRUITING

    Paris, 75015, France

  • IRCCS Istituto Giannina Gaslini

    RECRUITING

    Genoa, Liguria, 16147, Italy

  • Institute for Mother and Child healthcare "Dr Vukan Cupic"

    RECRUITING

    Belgrade, 11000, Serbia

  • Institute of hematology&blood disease hospital

    RECRUITING

    Tianjin, Tianjin Municipality, China

  • Istanbul Universitesi Klinik Arastirmalar Mukemmeliyet Uygulama ve Arastirma Merkezi

    RECRUITING

    Istanbul, 34452, Turkey (Türkiye)

  • Istanbul University Oncology Institute

    RECRUITING

    Istanbul, 34093, Turkey (Türkiye)

  • Istituto Clinico Humanitas

    RECRUITING

    Rozzano, Milano, 20089, Italy

  • Jiangxi Provincial People's Hospital

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • Jiangxi Provincial People's Hospital

    RECRUITING

    Nanchang, Jiangxi, 330038, China

  • K.J Somaiya Hospital & Research Centre, Somaiya Ayurvihar Complex

    RECRUITING

    Mumbai, Maharashtra, 400022, India

  • Klinicki bolnicki centar Zagreb

    RECRUITING

    Zagreb, 10000, Croatia

  • Kyung Hee University Hospital at Gangdong

    RECRUITING

    Seoul, Seoul-teukbyeolsi [seoul], 05278, South Korea

  • Kyungpook National University Hospital

    RECRUITING

    Daegu, Taegu-kwangyǒkshi, 41944, South Korea

  • Nagano Children's Hospital

    RECRUITING

    Azumino, Nagano, 399-8288, Japan

  • Nagoya University Hospital - Transfusion Medicine

    RECRUITING

    Nagoya, Aichi-ken, 466-8560, Japan

  • Nanfang Hospital, Southern Medical University

    RECRUITING

    Guangzhou, Guangdong, 510515, China

  • Nara Medical University Hospital

    RECRUITING

    Kashihara, Nara, 634-0813, Japan

  • Nil Ratan Sircar Medical College and Hospital

    RECRUITING

    Kolkata, West Bengal, 700014, India

  • Nirmal Hospital Pvt Ltd.

    RECRUITING

    Surat, Gjuarat, 395002, India

  • Northwell Health HTC

    RECRUITING

    New Hyde Park, New York, 11040, United States

  • Ondokuz Mayıs University Healthcare Practice and Research Center

    RECRUITING

    Samsun, 55200, Turkey (Türkiye)

  • Ondokuz Mayıs University Medical Faculty Local Laboratory

    RECRUITING

    Samsun, 55280, Turkey (Türkiye)

  • Prince of Wales Hospital

    RECRUITING

    Hong Kong, Hong Kong

  • Queen Mary Hospital

    RECRUITING

    Hong Kong, Hong Kong

  • Royal Children's Hospital

    RECRUITING

    Melbourne, Victoria, 3052, Australia

  • Royal Victoria Infirmary

    RECRUITING

    Newcastle upon Tyne, England, NE1 4LP, United Kingdom

  • Saga University Hospital

    RECRUITING

    Saga, 849-8501, Japan

  • Sahyadri Super Speciality Hospital

    RECRUITING

    Pune, Maharashtra, 411004, India

  • Saitama Children's Medical Center

    RECRUITING

    Saitama-shi, Saitama, 330-8777, Japan

  • Saitama Medical University Hospital

    RECRUITING

    Lruma-gun, Saitama, 350-0495, Japan

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, Seoul-teukbyeolsi[seoul], 03722, South Korea

  • Sheba Medical Center

    RECRUITING

    Ramat Gan, Central District, 5262100, Israel

  • Stollery Children's Hospital

    RECRUITING

    Edmonton, Alberta, T6G 2B7, Canada

  • Sultan Qaboos University Hospital

    RECRUITING

    Muscat, 123, Oman

  • Taichung Veterans General Hospital

    RECRUITING

    Taichung, 407219, Taiwan

  • The Affiliated Hospital of Guizhou Medical University

    RECRUITING

    Guiyang, Guizhou, 550004, China

  • The Chinese University of Hong Kong

    RECRUITING

    Ma Liu Shui, Hong Kong

  • The Feinstein Institutes for Medical Research

    RECRUITING

    Philadelphia, Pennsylvania, 19195, United States

  • The University of Hong Kong (HKU)-Queen Mary Hospital (QMH)

    RECRUITING

    Hong Kong, 999077, Hong Kong

  • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430030, China

  • University of Iowa

    ACTIVE_NOT_RECRUITING

    Iowa City, Iowa, 52242, United States

  • Univerzitna nemocnica Martin

    RECRUITING

    Martin, 036 59, Slovakia

  • WITS Health Consortium

    ACTIVE_NOT_RECRUITING

    Johannesburg, Gauteng, 2193, South Africa

  • Washington Institute for Coagulation d/b/a WACBD

    RECRUITING

    Seattle, Washington, 98101, United States

  • Worthwhile Clinical Trials

    ACTIVE_NOT_RECRUITING

    Benoni, Gauteng, 1500, South Africa

More trials for these conditions

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