drugset / Trial / NCT04286412

Nonacog Alfa Prophylaxis And Treatment Of Bleeding Episodes In Previously Treated Patients With Hemophilia B

NCT04286412 ↗

Phase 4 Completed 25 enrolled Pfizer
NaSingle-groupOpen-labelTreatment

Summary

Nonacog alfa is indicated for the control and prevention of hemorrhagic episodes and for routine and surgical prophylaxis in patients with hemophilia B. The current single country, multi-centric, open label, non-randomized clinical trial is a post-approval study to fulfill the Central Drugs Standard Control Organization (CDSCO) request for supplementary information relating to the use of nonacog alfa in Indian subjects with hemophilia B.

Timeline

Start
2020-02-10
Primary completion
2020-09-24
Completion
2020-09-24

Drugs

EvaluationDrugModalityDoseRoute
Subject BeneFIX Protein / enzyme biologic — —

Indications