Octocog alfa

DRUG5 trials

Sponsors

CSL Behring, Baxalta now part of Shire, Spanish Society of Thrombosis and Haemostasis, Sanofi, Bayer

Conditions

Factor VIII DeficiencyHemophiliaHemophilia A

Phase 1

BAX 826 Dose-Escalation Safety Study

CompletedNCT02716194

Baxalta now part of ShireHemophilia A

Start: 2016-03-03End: 2017-01-17Updated: 2021-05-25

Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A

CompletedNCT05042440

SanofiHemophilia A

Start: 2021-08-11End: 2021-11-24Updated: 2025-09-18

Phase 2

An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A

CompletedNCT01486927

CSL BehringHemophilia A

Start: 2012-02-29End: 2014-12-31Updated: 2016-08-09

Unknown Phase

Pharmacokinetic Characterization of the Hemophilia A Population in Spain Using myPKFiT®

CompletedNCT03006965

Spanish Society of Thrombosis and HaemostasisFactor VIII Deficiency, Hemophilia, Hemophilia A

Start: 2016-11-11End: 2022-12-22Updated: 2023-06-08

Post Approval Observational Study to Learn More About How Safe Octocog Alfa is and How Well it Works in Patients With Severe Hemophilia A in India

Not yet recruitingNCT07446010

BayerHemophilia A

Start: 2026-09-01End: 2027-09-30Target: 33Updated: 2026-06-18

Related Papers

Efanesoctocog Alfa Population Pharmacokinetics and Repeated Time‐To‐Event Analysis of Bleeds in Adults, Adolescents, and Children with Severe Hemophilia A

The Journal of Clinical Pharmacology2025-03-231 citations

Perioperative Management With Efanesoctocog Alfa in Patients With Haemophilia A in the Phase 3 XTEND‐1 and XTEND‐Kids Studies

Haemophilia2025-03-183 citations

Pharmacokinetics of recombinant factor VIII in adults with severe hemophilia A: fixed-sequence single-dose study of octocog alfa, rurioctocog alfa pegol, and efanesoctocog alfa.

2023-05-139 citations

SHP656, a polysialylated recombinant factor VIII (PSA‐rFVIII): First‐in‐human study evaluating safety, tolerability and pharmacokinetics in patients with severe haemophilia A

Haemophilia2019-11-288 citations

Efficacy and safety of rVIII-SingleChain: results of a phase 1/3 multicenter clinical trial in severe hemophilia A

Blood2016-06-2385 citations