WO45886 (ZEBRHA 1)
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 FACTOR VIII PROPHYLAXIS IN PEOPLE WITH HEMOPHILIA A WITHOUT INHIBITORS
IRAS ID
1013205
Contact name
Anna Dziag
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 factor eight on patients.
In this study, participants will receive either NXT007 or factor eight regularly to prevent bleeding (prophylaxis treatment). The goal is
to see how NXT007 protects participants from bleeding compared to factor eight.
NXT007 is an experimental study drug, which means health authorities have not approved NXT007 for the treatment of haemophilia A. NXT007 has been tested in people with haemophilia A in smaller studies.
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 A.
Approximately 23 participants will take part in the study in the UK and 126 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 23 visits if participating in Group 1 (NXT007 arm) or 26 visits if participating in Group 2 (factor eight arm) visits 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 factor eight which will be administered using a handheld syringe to injected 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 factor eight at home, after they were trained.REC name
East of Scotland Research Ethics Service REC 2
REC reference
26/ES/0029
Date of REC Opinion
18 May 2026
REC opinion
Further Information Favourable Opinion