A Long-Term Follow-Up Study in Severe Hemophilia A Subjects Who Received BMN 270 in a Prior BioMarin Clinical Trial (270-401)

NCT ID: NCT05768386

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

172 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2040-01-31

Brief Summary

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The BMN 270 clinical development program consists of multiple interventional studies designed to assess the safety and efficacy of a single infusion of BMN 270 for at least 5 years post-infusion. This long-term follow-up study is needed to help further understand the long-term safety of BMN 270 beyond 5 years and to assess the durability of efficacy.

Detailed Description

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Study 270-401 will collect additional follow-up data in a single study for approximately 10 years among all subjects who consent to participate and have completed their primary treatment study (ie, for any study in which they received BMN 270).

Conditions

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Hemophilia A

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Participants must have completed their primary treatment study or be currently enrolled in the primary treatment study at the time of closure by the Sponsor. Participants may enroll in 270-401 even if they have restarted FVIII prophylaxis or other hemophilia A treatment.
* Subjects must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. If the subject is unable to provide consent, a legally authorized representative may provide written informed consent.

Exclusion Criteria

* Participants who do not directly enroll in 270-401 at the time of the study completion visit in their primary treatment study should enroll in 270-401 within 4 months of the date of that study completion visit. If a participant wishes to enroll in 270-401 after 4 months, they must receive prior approval from the Medical Monitor.
* Participants must be overtly healthy and not have any condition that, in the opinion of the Investigator or Medical Monitor, would prevent the participant from fully complying with the requirements of the study and/or would impact or interfere with evaluation and interpretation of the study data (including, if applicable, advanced HIV disease).
* Where applicable, per country regulation, the participant must not currently be committed to an institution by virtue of an order issued either by judicial or administrative authorities.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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BioMarin Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director, MD

Role: STUDY_DIRECTOR

BioMarin Pharmaceutical

Locations

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Orthopedic Institute for Children, Orthopedic Hemophilia Treatment Center

Los Angeles, California, United States

Site Status

UC Davis Hemophilia Treatment Center

Sacramento, California, United States

Site Status

University of California San Diego, Hemophilia & Thrombosis Treatment Center

San Diego, California, United States

Site Status

University of California San Francisco - Moffit Hospital, Outpatient Hematology Clinic

San Francisco, California, United States

Site Status

UCN Hemophilia and Thrombosis Center

Shandon, California, United States

Site Status

Hemophilia and Thrombosis Center at the University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

St Joseph's Children's Hospital, Center for Bleeding and Clotting Disorders

Tampa, Florida, United States

Site Status

University Medical Center, Inc,; DBA University of Louisville Hospital, James Graham Brown Cancer Center

Louisville, Kentucky, United States

Site Status

University of Michigan, Pediatric Hematology and Oncology

Ann Arbor, Michigan, United States

Site Status

Children's Hospital of Michigan, Hemophilia and Thrombosis Center

Detroit, Michigan, United States

Site Status

Washington University School of Medicine, Department of Pediatrics, Division of Hematology/Oncology

St Louis, Missouri, United States

Site Status

Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Hemophilia Center of Western Pennsylvania

Pittsburgh, Pennsylvania, United States

Site Status

Royal Prince Alfred Hospital, Institute of Haematology

Sydney, New South Wales, Australia

Site Status

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Site Status

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status

The Alfred Hospital

Melbourne, Victoria, Australia

Site Status

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Site Status

University Hospitals Leuven, Campus Gasthuisberg, Department of Heart and Vascular Disease

Leuven, , Belgium

Site Status

Holy Spirit Hematology and Hemotherapy Center

Vitória, Espírito Santo, Brazil

Site Status

Arthur De Siqueira Cavalcanti Hematology State Institute / Coordinating Hemocenter

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Campinas University Clinical Hospital, Hematology and Hemotherapy Center (Hemocentro UNICAMP)

Campinas, São Paulo, Brazil

Site Status

Sao Paulo University Clinical Hospital

São Paulo, São Paulo, Brazil

Site Status

CHRU Lille Hospital Center Heart-Lung Institute

Lille, , France

Site Status

CHU La Timone - La Timone Children's Hospital

Marseille, , France

Site Status

University Hospital Bonn, Institute of Experimental Hematology and Transfusion Medicine, Hemophilia Care Center

Bonn, North Rhine-Westphalia, Germany

Site Status

Vivantes Hospital in Friedrichshain

Berlin, State of Berlin, Germany

Site Status

Chaim Sheba Medical Center, National Institute of Hemophilia and Coagulation

Ramat Gan, , Israel

Site Status

Maggiore Polyclinic Hospital, Foundation IRCCS Ca' Granda, Center for Hemophilia and Thrombosis "Angelo Bianchi Bonomi"

Milan, , Italy

Site Status

Charlotte Maxeke Johannesburg Academic Hospital, Hemophilia Comprehensive Care Center

Johannesburg, , South Africa

Site Status

Kyung Hee University Hospital at Gangdong

Seoul, , South Korea

Site Status

University Hospital Virgen del Rocio (HUVR), Hematology Pediatrics

Seville, Andalusia, Spain

Site Status

Hospital Teresa Herrera, Department of Hematology and Hemotherapy, Unit of Hemostasis and Thrombosis

A Coruña, Galicia, Spain

Site Status

Addenbrooke's Hospital, Hemophilia and Thrombophilia Center

Cambridge, , United Kingdom

Site Status

Glasgow Royal Infirmary, Department of Hematology

Glasgow, , United Kingdom

Site Status

Hammersmith Hospital, Clinical Research Facility, Centre for Translational and Experimental Medicine

London, , United Kingdom

Site Status

Queen Elizabeth Hospital Birmingham. Adult Hemophilia Centre, West Midlands Adult Comprehensive Care Hemophilia Centre

London, , United Kingdom

Site Status

Royal London Hospital, Barts and the London Hemophilia Center

London, , United Kingdom

Site Status

St Thomas' Hospital, Centre for Hemophilia, Hemostasis and Thrombosis

London, , United Kingdom

Site Status

Nuffield Orthopaedic Centre, Hemophilia & Thrombosis Center

Oxford, , United Kingdom

Site Status

University Hospital Southampton NHS Foundation Trust

Southampton, , United Kingdom

Site Status

Countries

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United States Australia Belgium Brazil France Germany Israel Italy South Africa South Korea Spain United Kingdom

Other Identifiers

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2022-001246-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

270-401

Identifier Type: -

Identifier Source: org_study_id

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