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A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A

Study acronym: ZEBRHA 1
StatusRecruiting
PhasePhase 3
Started2026-05-15
View on ClinicalTrials.gov ↗

Amendment history

2026-09-03
Study Status, Study Description, Contacts/Locations v7
Trial sites expanded: 27 → 32 locations
Trial sites expanded: 19 → 27 locations
2026-08-04
Study Status, Contacts/Locations v6
Trial sites expanded: 2 → 19 locations
2026-07-03
Study Status, Contacts/Locations v5
Re-verified, no change to tracked fields
2026-06-04
Study Status, Contacts/Locations, References v4
Start dateestimated 2026-05-09→confirmed 2026-05-15
2026-05-06
Study Status v3
Re-verified, no change to tracked fields
2026-04-08
Study Status, Contacts/Locations v2
Recruitment opened
Study sites0→2
2026-03-10
Study Status v1
Re-verified, no change to tracked fields
2026-02-11
Original filing
Roche/Genentech
364 trials monitored
See 34 trials at risk
Hemophilia
231 trials monitored
See 10 trials at risk
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 FVIII inhibitors. The study will include people aged ≥12 years old who have been on FVIII prophylaxis treatment prior to study entry.
Trial Details
NCT Number NCT07416526
Lead Sponsor Hoffmann-La Roche
Collaborators: Chugai Pharmaceutical
Conditions Hemophilia A
Enrollment 138 participants
Start Date 2026-05-15
Primary Completion 2027-09-23 (estimated)
Study Completion 2031-09-23 (estimated)
Updated on ClinicalTrials.gov 2026-09-23