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An Open-Label, Comparative Study of the Efficacy, Safety and Pharmacodynamics of Single Dose of ANB-002 in Patients With Hemophilia B

Study acronym: MAGNOLIA
StatusRecruiting
PhasePhase 3
SponsorBiocad
Started2024-11-07
View on ClinicalTrials.gov ↗

Amendment history

2025-11-17
minor
Study Status, Contacts/Locations v3
Study sites11→14
2025-06-10
minor
Study Status, Arms and Interventions v2
Re-verified, no change to tracked fields
2025-02-19
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Oversight, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-12→confirmed 2024-11-07
Study sitesdetails revised at 11 of 11 sites
Study titlerevised
An Open-Label, Comparative Study of the Efficacy, Safety and Pharmacodynamics of Single Dose of ANB-002 in Patients withWith Hemophilia B
2024-11-19
minor
Original filing
26 trials monitored
See all monitored trials
231 trials monitored
See 10 trials at risk
The aim of the study is to demonstrate non-inferiority of ANB-002 compared with preventive use of coagulation factor IX (FIX) in adult subjects with hemophilia B with FIX activity ≤2% and without FIX inhibitor. The study will have an open-label single-arm design.
Trial Details
NCT Number NCT06700096
Lead Sponsor Biocad
Conditions Hemophilia B
Enrollment 24 participants
Start Date 2024-11-07
Primary Completion 2027-04 (estimated)
Study Completion 2032-03 (estimated)
Updated on ClinicalTrials.gov 2025-11-18