Hemophilia APhase 3ZEBRHA 1NCT07416526
A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A
A Phase 3 study testing NXT007 and Human Coagulation Factor VIII in people with Hemophilia A, run by Hoffmann-La Roche at 36 sites in 18 countries.
Trial summary
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of NXT007 prophylaxis compared with Factor VIII (FVIII) prophylaxis in participants with severe or moderate congenital hemophilia A without FVIII inhibitors. 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 Human Coagulation Factor VIII
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 36 sitesin 18 countries
- Study dates
- 15 May 2026to 23 Sep 2031
- 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 IU/dL [International Unit per decilitre]) or moderate (FVIII:C between ≥1 IU/dL and ≤5 IU/dL) congenital hemophilia A without inhibitors against FVIII
- No documented inhibitor (i.e., <0.6 BU/mL [Bethesda unit per millilitre]), FVIII half-life ≥6 hours, or FVIII recovery >66% in the last 3 years prior to screening
- Documented historical negative test for FVIII inhibitor (i.e., <0.6 BU/mL) within 12 months prior to enrollment
- Documentation of the details of prophylactic and episodic FVIII treatment and of the number and type of bleeding episodes for at least the last 6 months prior to screening
- Agreement to adhere to the contraception requirements (for potential participants with childbearing potential)
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 anti-retroviral therapy to treat HIV
- Planned surgery (excluding minor procedures such as non-molar tooth extraction, incision and drainage) during the study
- 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 ECG evidence or clinical history of prior myocardial infarction
- Refusal to accept plasma-derived and/or blood product transfusion support in an emergency scenario
- 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)
Trial locations and contacts
36 sites in 18 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: WO45886 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
36 sites in 18 countries
Spain5 sites, 5 recruiting
- Recruiting
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 08035
- 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
Italy4 sites, 4 recruiting
- 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
United Kingdom4 sites, 4 recruiting
- Recruiting
University Hospital of Wales
Cardiff, CF14 4XW
- Recruiting
The Royal London Hospital
London, Middlesex, E1 1FR
- Recruiting
St Thomas' Hospital
London, SE1 7EH
- Recruiting
Churchill Hospital
Oxford, OX3 7LE
France3 sites, 3 recruiting
- Recruiting
Groupement Hospitalier Est-Hopital Femme Mere enfant/Hospice 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
United States2 sites, 2 recruiting
- Recruiting
University of Colorado Hemophilia and Thrombosis Center
Aurora, Colorado, 80045-7202
- Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242-1009
Argentina2 sites, 2 recruiting
- Recruiting
Arbesu Hematologia
Godoy Cruz, Mendoza Province, M5504FKD
- Recruiting
Instituto de Hematología Y Medicina Clínica Dr. Rubén Dávoli
Rosario, Santa Fe Province, S2000CFK
Brazil2 sites, 2 recruiting
- Recruiting
Hemocentro Da UNICAMP
Campinas, São Paulo, 13083-878
- Recruiting
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP - PPDS
Ribeirão Preto, São Paulo, 14051-140
Japan2 sites, 2 recruiting
- Recruiting
Nara Medical University Hospital
Kashihara-shi, Nara, 634-8522
- Recruiting
Tokyo Medical University Hospital
Shinjuku-Ku, Tokyo, 160-0023
South Korea2 sites, 2 recruiting
- Recruiting
Kyung Hee University Hospital at Gangdong
Gangdong-gu, Seoul, 05278
- Recruiting
Chonnam National University Hwasun Hospital
Hwasun-gun, 58128
Taiwan2 sites, 2 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, 40705
- Recruiting
Tri-Service General Hospital
Taipei, 11490
Austria1 site, 1 recruiting
- Recruiting
Universitätsklinikum AKH Wien
Vienna, 1090
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet-Blegdamsvej 9
Copenhaen, 2100
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, 53127
Hungary1 site, 1 recruiting
- Recruiting
Eszak-Pesti Centrumkorhaz -Honvedkorhaz
Budapest, Pest County, 1134
Netherlands1 site, 1 recruiting
- Recruiting
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
South Africa1 site, 1 recruiting
- Recruiting
Haemophilia Comprehensive Care Centre
Parktown, Gauteng, 2193
Switzerland1 site, 1 recruiting
- Recruiting
Universitätsspital Zürich
Zurich, 8091
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 Factor VIII Prophylaxis in People With Hemophilia A Without Inhibitors
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of NXT007 prophylaxis compared with Factor VIII (FVIII) prophylaxis in participants with severe or moderate congenital hemophilia A without FVIII inhibitors. The study will include people aged ≥12 years old who have been on FVIII prophylaxis treatment prior to study entry.
- Conditions
- Hemophilia A
- Being tested
- NXT007, Human Coagulation Factor VIII
- 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.
Human Coagulation Factor VIIIDrug
Factor VIII (FVIII) prophylaxis standard of care (SOC) will be administered at the dose and frequency as stated in the local labels and per local country practice.
| Study group | Role | What they receive |
|---|---|---|
| Main Study Treatment Period: NXT007 Prophylaxis | Experimental | Participants randomized to this arm will receive NXT007 prophylaxis for the main study treatment period. Receives: Combination Product: NXT007 |
| Main Study Treatment Period: FVIII SOC Prophylaxis | Active comparator | Participants randomized to this arm will receive FVIII standard of care (SOC) prophylaxis for the main study treatment period. Receives: Drug: Human Coagulation Factor VIII |
| Open-Label Extension Period: NXT007 Prophylaxis | Experimental | After the main study treatment period, participants in the NXT007 arm will be able to continue with NXT007 dosing, and participants in the FVIII 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.
Annualized Bleed Rate (ABR) for Treated Bleeds Over the Main Study Treatment Period
Measured: 6 months
Secondary outcomes (22)
ABR for All Bleeds Over the Main Study Treatment Period
Measured: 6 months
ABR for Treated Spontaneous Bleeds Over the Main Study Treatment Period
Measured: 6 months
ABR for Treated Joint Bleeds Over the Main Study Treatment Period
Measured: 6 months
Adjusted Mean Treatment Burden Domain Score in Comprehensive Assessment Tool of Challenges in Hemophilia (CATCH) Questionnaire - Adult Version at Month 7
Measured: Month 7
ABR for Treated Target Joint Bleeds Over the Main Study Treatment Period
Measured: 6 months
Percentage of Participants with Zero Treated Bleeds Over the Main Study Treatment Period
Measured: 6 months
Number of Injections and Dose per Bleed of Coagulation Factors Administered to Treat a Bleed Over the Main Study Treatment Period
Measured: 6 months
Annualized FVIII Injection Rate Over the Main Study Treatment Period
Measured: 6 months
Annualized FVIII Consumption Rate Over the Main Study Treatment Period
Measured: 6 months
Mean Treatment Burden Domain Score in CATCH Questionnaire - Adolescent Version at Month 7
Measured: Month 7
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)
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)
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)
Physical Impact Domain Score of the Treatment Administration Satisfaction Questionnaire (TASQ) at Specified Timepoints
Measured: At prespecified timepoints from Baseline to Month 10
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)
Incidence and Severity of Thromboembolic Events and Thrombotic Microangiopathy
Measured: From Baseline until Study Completion (approximately 3.5 years)
Incidence and Severity of Injection-Site Reactions
Measured: From Baseline until Study Completion (approximately 3.5 years)
Incidence of Adverse Events Leading to Discontinuation of Assigned Study Treatment
Measured: From Baseline until Study Completion (approximately 3.5 years)
Incidence of Severe Hypersensitivity, Anaphylaxis, or Anaphylactoid Reactions
Measured: From Baseline until Study Completion (approximately 3.5 years)
Plasma Concentration of NXT007
Measured: At prespecified timepoints from Baseline to Study Completion (approximately 3.5 years)
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)
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.
- First posted18 Feb 2026
- Study start15 May 2026
- Primary completion23 Sep 2027 (estimated)
- Study completion23 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chugai Pharmaceutical
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416526
- Sponsor's protocol ID
- WO45886
- Other IDs
- 2025-522434-32-00, 2025
- Acronym
- ZEBRHA 1
- Status last verified
- Oct 2026
- First submitted
- 11 Feb 2026
- Last updated
- 26 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of NXT007 Prophylaxis Versus Factor VIII Prophylaxis in People With Hemophilia A Without Inhibitors
- ClinicalTrials.gov ID
- NCT07416526
- Acronym / sponsor ID
- ZEBRHA 1 / WO45886
- Conditions
- Hemophilia A
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Chugai Pharmaceutical
- Study start
- 15 May 2026 (actual)
- Primary completion
- 23 Sep 2027 (estimated)
- Study completion
- 23 Sep 2031 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of NXT007 prophylaxis compared with Factor VIII (FVIII) prophylaxis in participants with severe or moderate congenital hemophilia A without FVIII inhibitors. The study will include people aged ≥12 years old who have been on FVIII prophylaxis treatment prior to study entry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Main Study Treatment Period: NXT007 Prophylaxis | Experimental | Combination Product: NXT007Participants randomized to this arm will receive NXT007 prophylaxis for the main study treatment period. |
| Main Study Treatment Period: FVIII SOC Prophylaxis | Active comparator | Drug: Human Coagulation Factor VIIIParticipants randomized to this arm will receive FVIII standard of care (SOC) prophylaxis for the main study treatment period. |
| Open-Label Extension Period: NXT007 Prophylaxis | Experimental | Combination Product: NXT007After the main study treatment period, participants in the NXT007 arm will be able to continue with NXT007 dosing, and participants in the FVIII arm will be able to switch to NXT007, in the open-label extension period. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of severe (FVIII:C <1 IU/dL [International Unit per decilitre]) or moderate (FVIII:C between ≥1 IU/dL and ≤5 IU/dL) congenital hemophilia A without inhibitors against FVIII
- No documented inhibitor (i.e., <0.6 BU/mL [Bethesda unit per millilitre]), FVIII half-life ≥6 hours, or FVIII recovery >66% in the last 3 years prior to screening
- Documented historical negative test for FVIII inhibitor (i.e., <0.6 BU/mL) within 12 months prior to enrollment
- Documentation of the details of prophylactic and episodic FVIII treatment and of the number and type of bleeding episodes for at least the last 6 months prior to screening
- Agreement to adhere to the contraception requirements (for potential participants with childbearing potential)
Key exclusion criteria (6 listed)
- 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 anti-retroviral therapy to treat HIV
- Planned surgery (excluding minor procedures such as non-molar tooth extraction, incision and drainage) during the study
- 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 ECG evidence or clinical history of prior myocardial infarction
- Refusal to accept plasma-derived and/or blood product transfusion support in an emergency scenario
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NXT007Also: Zemocimig, RO7589655, RG6512NXT007 will be administered subcutaneously (SC) using an integrated drug-device combination product. | Combination product | Main Study Treatment Period: NXT007 Prophylaxis, Open-Label Extension Period: NXT007 Prophylaxis |
| Human Coagulation Factor VIIIFactor VIII (FVIII) prophylaxis standard of care (SOC) will be administered at the dose and frequency as stated in the local labels and per local country practice. | Drug | Main Study Treatment Period: FVIII SOC Prophylaxis |
Primary outcome
Annualized Bleed Rate (ABR) for Treated Bleeds Over the Main Study Treatment Period
Time frame: 6 months
22 secondary outcomes
ABR for All Bleeds Over the Main Study Treatment Period
Time frame: 6 months
ABR for Treated Spontaneous Bleeds Over the Main Study Treatment Period
Time frame: 6 months
ABR for Treated Joint Bleeds Over the Main Study Treatment Period
Time frame: 6 months
Adjusted Mean Treatment Burden Domain Score in Comprehensive Assessment Tool of Challenges in Hemophilia (CATCH) Questionnaire - Adult Version at Month 7
Time frame: Month 7
ABR for Treated Target Joint Bleeds Over the Main Study Treatment Period
Time frame: 6 months
Percentage of Participants with Zero Treated Bleeds Over the Main Study Treatment Period
Time frame: 6 months
Number of Injections and Dose per Bleed of Coagulation Factors Administered to Treat a Bleed Over the Main Study Treatment Period
Time frame: 6 months
Annualized FVIII Injection Rate Over the Main Study Treatment Period
Time frame: 6 months
Annualized FVIII Consumption Rate Over the Main Study Treatment Period
Time frame: 6 months
Mean Treatment Burden Domain Score in CATCH Questionnaire - Adolescent Version at Month 7
Time frame: Month 7
Change From Baseline in Preoccupation Domain Score of the CATCH Questionnaire (Adult and Adolescent Versions)
Time frame: At prespecified timepoints from Baseline until Study Completion (approximately 3.5 years)
Change From Baseline in Social Activity Impact Domain Score of the CATCH Questionnaire (Adult and Adolescent Versions)
Time frame: At prespecified timepoints from Baseline until Study Completion (approximately 3.5 years)
Change From Baseline in Recreational Activity Impact Domain Score of the CATCH Questionnaire (Adult and Adolescent Versions)
Time frame: At prespecified timepoints from Baseline until Study Completion (approximately 3.5 years)
Physical Impact Domain Score of the Treatment Administration Satisfaction Questionnaire (TASQ) at Specified Timepoints
Time frame: At prespecified timepoints from Baseline to Month 10
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
Time frame: From Baseline until Study Completion (approximately 3.5 years)
Incidence and Severity of Thromboembolic Events and Thrombotic Microangiopathy
Time frame: From Baseline until Study Completion (approximately 3.5 years)
Incidence and Severity of Injection-Site Reactions
Time frame: From Baseline until Study Completion (approximately 3.5 years)
Incidence of Adverse Events Leading to Discontinuation of Assigned Study Treatment
Time frame: From Baseline until Study Completion (approximately 3.5 years)
Incidence of Severe Hypersensitivity, Anaphylaxis, or Anaphylactoid Reactions
Time frame: From Baseline until Study Completion (approximately 3.5 years)
Plasma Concentration of NXT007
Time frame: At prespecified timepoints from Baseline to Study Completion (approximately 3.5 years)
Percentage of Participants With Anti-Drug Antibodies (ADAs) Against NXT007 at Baseline and During the Study
Time frame: At prespecified timepoints from Baseline to Study Completion (approximately 3.5 years)
Percentage of Participants With Neutralizing ADAs Against NXT007
Time frame: At prespecified timepoints from Baseline to Study Completion (approximately 3.5 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reference Study ID Number: WO45886 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
Clinical Trials study director
Hoffmann-La Roche
36 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NXT007 and Human Coagulation Factor VIII in people with Hemophilia A, run by Hoffmann-La Roche at 36 sites in 18 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 26 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 36 sites in Spain, Italy, United Kingdom, France, United States and 13 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: WO45886 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: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2026.