A Phase 3 interventional study of NXT007 and Human Coagulation Factor VIII in Hemophilia A, sponsored by Hoffmann-La Roche. Recruiting at 36 sites in 18 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
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.
844 studies on the registry are indexed under Hemophilia A; 138 are open to participants now.
This study's planned enrollment of 138 is above the median of 30 across 499 interventional studies indexed under Hemophilia A.
Browse Hemophilia A studies →Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to this arm will receive NXT007 prophylaxis for the main study treatment period.
Combination Product: NXT007
Participants randomized to this arm will receive FVIII standard of care (SOC) prophylaxis for the main study treatment period.
Drug: Human Coagulation Factor VIII
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.
Combination Product: NXT007
NXT007 will be administered subcutaneously (SC) using an integrated drug-device combination product.
Also known as: Zemocimig, RO7589655, RG6512
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.
Annualized Bleed Rate (ABR) for Treated Bleeds Over the Main Study Treatment Period
Time frame: 6 months
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)
Plan to share: 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
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: NXT007