RecruitingPhase 3NCT07416604

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

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

Sponsor

Hoffmann-La Roche

Enrollment

360 participants

Start Date

Apr 27, 2026

Study Type

INTERVENTIONAL

Conditions

Hemophilia A

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 (severe, moderate, and mild) with FVIII inhibitors.

Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Emicizumab and NXT007 for people with hemophilia a. The study is currently recruiting participants at 12 locations. People eligible for this study include aged 12 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTNXT007

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

DRUGEmicizumab

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

Locations(12)

Center for Inherited Blood Disorders

Orange, California, United States

Innovative Hematology, Inc.

Indianapolis, Indiana, United States

University Of Iowa Hospitals And Clinics

Iowa City, Iowa, United States

Washington Center for Bleeding Disorders

Seattle, Washington, United States

The Chaim Sheba Medical Center - PPDS

Ramat Gan, Central District, Israel

Nagoya University Hospital

Nagoya, Aiti, Japan

Gunma University Hospital

Maebashi, Gunma, Japan

Nara Medical University Hospital

Kashihara-shi, Nara, Japan

Ogikubo Hospital

Suginami-Ku, Tokyo, Japan

Hospital Universitario La Paz - PPDS

Madrid, Spain

Hospital Regional Universitario de Malaga ? Hospital General

Málaga, Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Spain

View Full Details on ClinicalTrials.gov

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NCT07416604

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