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ZEBRHA 1NXT007 vs. Factor VIII Prophylaxis in Hemophilia A Without Inhibitors

Study Aim

This study aims to compare the effectiveness of NXT007 and Factor VIII Prophylaxis in reducing the annual rate of treated bleeds in individuals with Hemophilia A who do not have inhibitors.

What is being tested

NXT007

+ Human Coagulation Factor VIII

Combination ProductDrug

Who is being recruted

Blood Coagulation Disorders+6

+ Hematologic Diseases

+ Hemic and Lymphatic Diseases

Over 12 Years

+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: May 2026

See protocol details

Summary

Principal SponsorHoffmann-La Roche

Study ContactReference Study ID Number: WO45886 https://forpatients.roche.com/

Last updated: March 13, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: May 9, 2026

Actual date on which the first participant was enrolled.

This study focuses on comparing two treatments, NXT007 and Factor VIII (FVIII), for individuals with severe or moderate congenital hemophilia A who do not have inhibitors. Hemophilia A is a genetic disorder that impairs the body's ability to clot blood, leading to extended bleeding. The study aims to find out if NXT007 is as effective and safe as the current standard treatment, FVIII. It includes individuals aged 12 years and older who have been previously treated with FVIII. The potential outcomes of this study could lead to an improved treatment option for hemophilia A patients, enhancing their quality of life and addressing current treatment challenges. During the study, participants receive either NXT007 or FVIII as a prophylactic treatment. The main goal is to measure the Annualized Bleed Rate (ABR), which counts the number of bleeds a person experiences in a year. This helps researchers compare the effectiveness of both treatments in preventing bleeding episodes. The study also evaluates the safety and how the body processes and responds to these treatments (pharmacokinetics and pharmacodynamics).

Official TitleA 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

NCT07416526

Principal SponsorHoffmann-La Roche

Study ContactReference Study ID Number: WO45886 https://forpatients.roche.com/

Last updated: March 13, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

126 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemophilia AHemorrhagic DisordersCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCoagulation Protein DisordersBlood Coagulation Disorders, InheritedGenetic Diseases, Inborn

Criteria

5 inclusion criteria required to participate

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

Agreement to adhere to the contraception requirements (for potential participants with childbearing potential)

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6 exclusion criteria prevent from participating

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

Refusal to accept plasma-derived and/or blood product transfusion support in an emergency scenario

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

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)

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants in this group receive NXT007 medication as a preventative measure during the main study period.

Group II

Experimental

After the main study, all participants can switch to or continue with NXT007 treatment. This is given using a special device under the skin.

Group III

Active Comparator

Participants in this group will receive the current standard care, Human Coagulation Factor VIII, as a preventive treatment. The dose and frequency will follow local guidelines and practices.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

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