Recruiting
Phase 3

NXT007 vs. FVIII

Sponsor:

Hoffmann-La Roche

Code:

NCT07416526

Conditions

Hemophilia A

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

NXT007

Human Coagulation Factor VIII

Study Details

Brief 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 inhibitors. The study will include people aged ≥12 years old with severe or moderate congenital hemophilia A without inhibitors on previous FVIII prophylaxis treatment.

Conditions

Hemophilia A

Study ID

NCT07416526

Start date

May 15, 2026

Status verified date

Aug, 2026

Completion date

Sep 23, 2031

Anticipated

Primary completion date

Sep 23, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Study Design

Enrollment

126 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Main Study Treatment Period: NXT007 Prophylaxis

Participants randomized to this arm will receive NXT007 prophylaxis for the main study treatment period.

active comparator: Main Study Treatment Period: FVIII SOC Prophylaxis

Participants randomized to this arm will receive FVIII standard of care (SOC) prophylaxis for the main study treatment period.

experimental: Open-Label Extension Period: NXT007 Prophylaxis

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.

Interventions

NXT007

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

Human Coagulation Factor VIII

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.

Primary outcome measure

  • Annualized Bleed Rate (ABR) for Treated Bleeds Over the Main Study Treatment Period [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

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

Locations

University of Colorado Hemophilia and Thrombosis Center

Recruiting

Aurora, Colorado, United States, 80045-7202

University of Iowa Hospitals and Clinics

Recruiting

Iowa City, Iowa, United States, 52242-1009

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-08-06.