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Hemophilia APhase 3ZEBRHA 2NCT07416604

A Clinical Study to Evaluate the Effects of NXT007 Compared to Emicizumab Prophylaxis in People With Hemophilia A

A Phase 3 study testing NXT007 and Emicizumab in people with Hemophilia A, run by Hoffmann-La Roche at 59 sites in 22 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of NXT007 prophylaxis compared with emicizumab prophylaxis in people age 12 years and older with severe or moderate congenital hemophilia A without factor VIII (FVIII) inhibitors or with hemophilia A of any severity… Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Hemophilia A
What is being tested?
NXT007 and Emicizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
59 sitesin 22 countries
Study dates
27 Apr 2026to 29 Jan 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Diagnosis of severe (FVIII:C <1 International Unit per decilitre [IU/dL]) or moderate (FVIII:C between ≥1 IU/dL and ≤5 IU/dL) congenital hemophilia A with or without inhibitors against FVIII
  • Diagnosis of mild (FVIII:C between >5 IU/dL and <40 IU/dL) congenital hemophilia A with chronic FVIII inhibitors, defined as documented FVIII inhibitor ( ≥0.6 BU/mL or ≥1.0 BU/mL only for laboratories with a historical sensitivity cutoff for inhibitor detection of 1.0 BU/mL) and chronic reduction of endogenous baseline FVIII:C to <5 IU/dL for ≥12 months
  • Documented historical FVIII inhibitor assay results within the 12 months prior to enrollment
  • Documentation of the details of prophylactic and episodic FVIII treatment, bypassing agent (BPA) treatment, emicizumab prophylaxis treatment, and the number and type of bleeding episodes for at least the last 6 months prior to screening
  • For potential participants taking on-demand treatments prior to study entry: agreement to move to a prophylaxis treatment with either emicizumab or NXT007, according to assigned randomization

Who cannot join

  • Sensitivity to any of the study investigations, or components thereof, or drug or other allergy that, in the opinion of the investigator, contraindicates participation in the study
  • Use of systemic immunomodulators (e.g., interferon or rituximab) at the time of enrollment or planned use during the study, except for antiretroviral therapy to treat HIV
  • Refusal to accept plasma-derived and/or blood product transfusion support in an emergency scenario
  • Planned surgery (excluding minor procedures, such as non-molar tooth extraction or incision and drainage) during the study
  • History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease (e.g., severe left ventricular systolic dysfunction, left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing)
  • History or presence of an abnormal ECG that is deemed clinically significant, (e.g., complete left bundle branch block, second- or third-degree atrioventricular heart block) or evidence or clinical history of prior myocardial infarction

Trial locations and contacts

59 sites in 22 countries. Contact the study team or a site near you to ask about taking part.

Reference Study ID Number: BO45887 https://forpatients.roche.com/ No attachments to email below. contact

888-662-6728 (U.S. Only)

global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact

59 sites in 22 countries

United States10 sites, 10 recruiting

  • University of Michigan - 1500 E Medical Center Dr

    Ann Arbor, Michigan, 48109-5000

    Recruiting

  • University of Colorado Hemophilia and Thrombosis Center

    Aurora, Colorado, 80045-7202

    Recruiting

  • Innovative Hematology, Inc.

    Indianapolis, Indiana, 46260

    Recruiting

  • University Of Iowa Hospitals And Clinics

    Iowa City, Iowa, 52242-1009

    Recruiting

  • University Of Miami Hospital

    Miami, Florida, 33136

    Recruiting

  • M Health Fairview - Pediatric Specialty Clinic-Discovery

    Minneapolis, Minnesota, 55454-1404

    Recruiting

  • Center for Inherited Blood Disorders

    Orange, California, 92868

    Recruiting

  • The University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

    Recruiting

  • Washington Center for Bleeding Disorders

    Seattle, Washington, 98101-3932

    Recruiting

  • St Joseph's Children's Hospital of Tampa

    Tampa, Florida, 33607-6307

    Recruiting

Other trials in United States

Spain6 sites, 6 recruiting

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 08035

    Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

    Recruiting

  • Hospital Universitario La Paz - PPDS

    Madrid, 28046

    Recruiting

  • Hospital Regional Universitario de Malaga ? Hospital General

    Málaga, 29010

    Recruiting

  • Hospital Universitario Virgen del Rocio - PPDS

    Seville, 41013

    Recruiting

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

    Recruiting

Other trials in Spain

China5 sites, 4 recruiting

  • Peking Union Medical College Hospital - East Campus

    Beijing, Beijing Municipality, 100730

    Recruiting

  • Chengdu Women's and Children's Central Hospital

    Chengdu, Sichuan, 610073

    Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

    Suspended

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515

    Recruiting

  • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 301617

    Recruiting

Other trials in China

United Kingdom5 sites, 5 recruiting

  • University Hospital of Wales

    Cardiff, CF14 4XW

    Recruiting

  • Royal Free Hospital - PPDS

    London, Camden, NW3 2QG

    Recruiting

  • St Thomas' Hospital

    London, Greater London, SE1 7EH

    Recruiting

  • The Royal London Hospital

    London, Middlesex, E1 1FR

    Recruiting

  • Great Ormond Street Hospital

    London, WC1N 3JH

    Recruiting

Other trials in United Kingdom

France4 sites, 4 recruiting

  • Hospices Civils de Lyon

    Bron, 69500

    Recruiting

  • AP-HP - Hôpital Bicêtre

    Le Kremlin-Bicêtre, Val-de-Marne, 94270

    Recruiting

  • CHU de Lille - Institut Cœur Poumon

    Lille, 59037

    Recruiting

  • AP-HP - Hôpital universitaire Necker-Enfants malades

    Paris, 75015

    Recruiting

Other trials in France

Italy4 sites, 4 recruiting

  • Azienda Ospedaliera Universitaria Careggi

    Florence, Tuscany, 50134

    Recruiting

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, Lombardy, 20122

    Recruiting

  • Azienda Ospedaliera Universitaria Federico II

    Naples, Campania, 80131

    Recruiting

  • IRCCS Istituto Clinico Humanitas

    Rozzano, Lombardy, 20089

    Recruiting

Other trials in Italy

Japan4 sites, 4 recruiting

  • Nara Medical University Hospital

    Kashihara-shi, Nara, 634-8522

    Recruiting

  • Gunma University Hospital

    Maebashi, Gunma, 371-8511

    Recruiting

  • Nagoya University Hospital

    Nagoya, Aiti, 466-8560

    Recruiting

  • Ogikubo Hospital

    Suginami-Ku, Tokyo, 167-0035

    Recruiting

Other trials in Japan

Netherlands3 sites, 3 recruiting

  • Amsterdam UMC Location AMC- Meibergdreef 9

    Amsterdam, North Holland, 1105 AZ

    Recruiting

  • Universitair Medisch Centrum Groningen

    Groningen, 9713 GZ

    Recruiting

  • Universitair Medisch Centrum Utrecht Cancer Center - PPDS

    Utrecht, 3584 CX

    Recruiting

Other trials in Netherlands

Argentina2 sites, 2 recruiting

  • Arbesu Hematologia

    Godoy Cruz, Mendoza Province, M5504FKD

    Recruiting

  • Instituto de Hematología Y Medicina Clínica Dr. Rubén Dávoli

    Rosario, Santa Fe Province, S2000CFK

    Recruiting

Other trials in Argentina

Australia2 sites, 2 recruiting

  • The Alfred Hospital

    Melbourne, Victoria, 3004

    Recruiting

  • Royal Children's Hospital Melbourne - PIN

    Parkville, Victoria, 3052

    Recruiting

Other trials in Australia

Belgium2 sites, 2 recruiting

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

    Recruiting

  • UZ Leuven

    Leuven, Antwerp, 3000

    Recruiting

Other trials in Belgium

New Zealand2 sites, 2 recruiting

  • Auckland City Hospital

    Auckland, 1023

    Recruiting

  • Wellington Hospital

    Wellington, 6021

    Recruiting

Other trials in New Zealand

Brazil1 site, 1 recruiting

  • Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP

    Ribeirão Preto, São Paulo, 14051-140

    Recruiting

Other trials in Brazil

Canada1 site, 1 recruiting

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

    Recruiting

Other trials in Canada

Denmark1 site, 1 recruiting

  • Rigshospitalet

    København Ø, Capital, 2100

    Recruiting

Other trials in Denmark

Germany1 site, 1 recruiting

  • Universitätsklinikum Bonn

    Bonn, North Rhine-Westphalia, 53127

    Recruiting

Other trials in Germany

Hungary1 site, 1 recruiting

  • Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus

    Debrecen, Pest County, 4032

    Recruiting

Other trials in Hungary

Ireland1 site, 1 recruiting

  • St James's Hospital

    Dublin, D08 NHY1

    Recruiting

Other trials in Ireland

Israel1 site, 1 recruiting

  • The Chaim Sheba Medical Center - PPDS

    Ramat Gan, Central District, 5262100

    Recruiting

Other trials in Israel

South Africa1 site, 1 recruiting

  • Haemophilia Comprehensive Care Centre

    Parktown, Gauteng, 2193

    Recruiting

Other trials in South Africa

South Korea1 site, 1 recruiting

  • Kyungpook National University Hospital

    Daegu, 41944

    Recruiting

Other trials in South Korea

Taiwan1 site, 1 recruiting

  • National Taiwan University Hospital

    Taipei, 10002

    Recruiting

Other trials in Taiwan

About this study

Official title: A Multicenter, Randomized, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of NXT007 Prophylaxis Versus Emicizumab Prophylaxis in People With Hemophilia A

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of NXT007 prophylaxis compared with emicizumab prophylaxis in people age 12 years and older with severe or moderate congenital hemophilia A without factor VIII (FVIII) inhibitors or with hemophilia A of any severity (severe, moderate, and mild) with FVIII inhibitors.

Conditions
Hemophilia A
Being tested
NXT007, Emicizumab
Medical subject headings
Hemophilia A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NXT007Combination product

    Also called Zemocimig, RO7589655, RG6512

    NXT007 will be administered subcutaneously (SC) using an integrated drug-device combination product.

  • EmicizumabDrug

    Also called Hemlibra, RO5534262, RG6013

    Emicizumab will be administered subcutaneously (SC) using vial and syringe.

Study groups in NCT07416604
Study groupRoleWhat they receive
Main Study Treatment Period: NXT007 ProphylaxisExperimentalParticipants randomized to this arm will receive NXT007 prophylaxis for the main study treatment period.
Receives: Combination Product: NXT007
Main Study Treatment Period: Emicizumab ProphylaxisActive comparatorParticipants randomized to this arm will receive emicizumab prophylaxis for the main study treatment period at 3 mg/kg once weekly (QW) for 4 weeks as loading doses, followed by maintenance dosing of either 1.5 mg/kg QW, 3 mg/kg once every 2 weeks (Q2W), or 6 mg/kg once every 4 weeks (Q4W). Loading doses are not required for participants who were taking emicizumab prior to study start.
Receives: Drug: Emicizumab
Open-Label Extension Period: NXT007 ProphylaxisExperimentalAfter the main study treatment period, participants in the NXT007 arm will be able to continue with NXT007 dosing, and participants in the Emicizumab arm will be able to switch to NXT007, in the open-label extension period.
Receives: Combination Product: NXT007

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Annualized Bleed Rate (ABR) for Treated Bleeds Over the Main Study Treatment Period

    Measured: From Month 2 until the clinical cutoff date (at least 7 months of study treatment)

Secondary outcomes (22)

  1. ABR for All Bleeds Over the Main Study Treatment Period

    Measured: From Month 2 until the clinical cutoff date (at least 7 months of study treatment)

  2. ABR for Treated Spontaneous Bleeds Over the Main Study Treatment Period

    Measured: From Month 2 until the clinical cutoff date (at least 7 months of study treatment)

  3. ABR for Treated Joint Bleeds Over the Main Study Treatment Period

    Measured: From Month 2 until the clinical cutoff date (at least 7 months of study treatment)

  4. Adjusted Mean Treatment Burden Domain Score in Comprehensive Assessment Tool of Challenges in Hemophilia (CATCH) Questionnaire - Adult Version at Month 8

    Measured: Month 8

  5. ABR for Treated Target Joint Bleeds Over the Main Study Treatment Period

    Measured: From Month 2 until the clinical cutoff date (at least 7 months of study treatment)

  6. Percentage of Participants with Zero Treated Bleeds Over the Main Study Treatment Period

    Measured: From Month 2 until the clinical cutoff date (at least 7 months of study treatment)

  7. Number of Injections and Dose per Bleed of Coagulation Factors or Bypassing Agent Administered to Treat a Bleed Over the Main Study Treatment Period

    Measured: From Month 2 until the clinical cutoff date (at least 7 months of study treatment)

  8. Annualized Injection Rate of FVIII or Bypassing Agent Over the Main Study Treatment Period

    Measured: From Month 2 until the clinical cutoff date (at least 7 months of study treatment)

  9. Annualized Consumption Rate of FVIII or Bypassing Agent Over the Main Study Treatment Period

    Measured: From Month 2 until the clinical cutoff date (at least 7 months of study treatment)

  10. Mean Treatment Burden Domain Score in CATCH Questionnaire - Adolescent Version at Month 8

    Measured: Month 8

  11. Change From Baseline in Preoccupation Domain Score of the CATCH Questionnaire (Adult and Adolescent Versions)

    Measured: At prespecified timepoints from Baseline until Study Completion (approximately 3.5 years)

  12. Change From Baseline in Social Activity Impact Domain Score of the CATCH Questionnaire (Adult and Adolescent Versions)

    Measured: At prespecified timepoints from Baseline until Study Completion (approximately 3.5 years)

  13. Change From Baseline in Recreational Activity Impact Domain Score of the CATCH Questionnaire (Adult and Adolescent Versions)

    Measured: At prespecified timepoints from Baseline until Study Completion (approximately 3.5 years)

  14. Physical Impact Domain Score of the Treatment Administration Satisfaction Questionnaire (TASQ) at Specified Timepoints

    Measured: At prespecified timepoints from Baseline to Month 4

  15. Incidence and Severity of Adverse Events, With Severity Determined According To National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE V5.0) Grading Scale

    Measured: From Baseline until Study Completion (approximately 3.5 years)

  16. Incidence and Severity of Thromboembolic Events and Thrombotic Microangiopathy

    Measured: From Baseline until Study Completion (approximately 3.5 years)

  17. Incidence and Severity of Injection-Site Reactions

    Measured: From Baseline until Study Completion (approximately 3.5 years)

  18. Incidence of Adverse Events Leading to Discontinuation of Assigned Study Treatment

    Measured: From Baseline until Study Completion (approximately 3.5 years)

  19. Incidence of Severe Hypersensitivity, Anaphylaxis, or Anaphylactoid Reactions

    Measured: From Baseline until Study Completion (approximately 3.5 years)

  20. Plasma Concentration of NXT007

    Measured: At prespecified timepoints from Baseline to Study Completion (approximately 3.5 years)

  21. Percentage of Participants With Anti-Drug Antibodies (ADAs) Against NXT007 at Baseline and During the Study

    Measured: At prespecified timepoints from Baseline to Study Completion (approximately 3.5 years)

  22. Percentage of Participants With Neutralizing ADAs Against NXT007

    Measured: At prespecified timepoints from Baseline to Study Completion (approximately 3.5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2026
  2. Study start27 Apr 2026
  3. Primary completion29 Feb 2028 (estimated)
  4. Study completion29 Jan 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07416604
Sponsor's protocol ID
BO45887
Other IDs
2025-522435-33-00, 2025
Acronym
ZEBRHA 2
Status last verified
Oct 2026
First submitted
11 Feb 2026
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NXT007 and Emicizumab in people with Hemophilia A, run by Hoffmann-La Roche at 59 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in United States, Spain, China, United Kingdom, France and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Reference Study ID Number: BO45887 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. Only), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized Bleed Rate (ABR) for Treated Bleeds Over the Main Study Treatment Period (time frame: From Month 2 until the clinical cutoff date (at least 7 months of study treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07416604.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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