drugset
drugset / Trial / NCT03855280

Evaluation of a Recombinant Factor IX Product, APVO101, in Previously-Treated Pediatric Patients With Hemophilia B

NCT03855280 ↗

Phase 3 Completed 21 enrolled Medexus Pharma, Inc.
NaSingle-groupOpen-labelTreatment

Summary

Phase 3/4, single arm, open-label study to evaluate PK, safety, and efficacy of APVO101 prophylaxis in severe or moderately severe hemophilia B subjects \< 12 years of age.

Timeline

Start
2020-01-16
Primary completion
2022-07-04
Completion
2022-07-04

Drugs

EvaluationDrugModalityDoseRoute
Subject APVO101 Protein / enzyme biologic 35 iu/kg Intravenous
Subject APVO101 Protein / enzyme biologic 75 iu/kg Intravenous

Indications

hemophilia B