ZEBHRA 2
Research type
Research Study
Full title
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
IRAS ID
1013139
Contact name
Anna Dziąg
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Clinicaltrials.gov Identifier
Research summary
This is a phase 3 study in patients age 12 years and older, living with severe or moderate haemophilia.
The purpose of this study is to compare the effects, good or bad, of a study drug called NXT007 versus emicizumab on patients.
In this study, participants will receive either NXT007 or emicizumab regularly to prevent bleeding (prophylaxis treatment). The goal is to see how NXT007 protects participants from bleeding compared to emicizumab.
Emicizumab is approved for the treatment of haemophilia. It is commonly used to treat people with severe or moderate haemophilia.
The aim of NXT007 is to provide protection from bleeding (prophylaxis) close to that of a person with a normal clotting system. It aims to provide this protection at a higher continuous level than existing prophylaxis treatments for haemophilia.
Approximately 34 participants will take part in the study in the UK and 360 worldwide.
Participants will be in the study for approximately 3.5 years. If they are among the first participants to join the study, their total time in the study could be about 4.5 years.
Participants will attend the hospital for 27 visits if participating in Group 1 (NXT007 arm) or 31 visits if participating Group 2 (emicizumab arm) during this time.
In Group 1, NXT007 will be administered using an autoinjector that injects NXT007 under the skin. The autoinjector will contain the correct dose of NXT007 based on the participant`s weight.
In Group 2, participants will receive emicizumab and they will be administered using a handheld syringe to inject emicizumab under the skin.
The study has four stages: screening, treatment period, treatment extension period and follow-up. Study participants will be required to undergo certain assessments at these visits.
Participants or their caregivers will be able to self-administer NXT007 and emicizumab at home, after they were trained.REC name
East of Scotland Research Ethics Service REC 2
REC reference
26/ES/0028
Date of REC Opinion
18 May 2026
REC opinion
Further Information Favourable Opinion