Optivate (factor VIII/von Willebrand factor) / Bio Products Lab - LARVOL DELTA

RESIST EXP: Rescue Immunotolerance Study in Induction of Immune Tolerance (ITI)-Experienced Patients (RES.I.S.T. Experienced) (clinicaltrials.gov) - P=N/A; N=3; Completed; Sponsor: City of Hope Medical Center; Active, not recruiting ➔ Completed; Trial completion date: Jun 2020 ➔ Oct 2020; Trial primary completion date: Jun 2020 ➔ Oct 2020

Clinical • Trial completion • Trial completion date • Trial primary completion date • Hematological Disorders • Hemophilia • Rare Diseases

RESIST NAIVE: Study of First TIME Immunotolerance Induction in Severe Hemophilia A Patients With Inhibitor at High Risk of Failure: Comparison With FVIII Concentrates With or Without Von Willebrand Factor - RES.I.S.T. Naive (clinicaltrials.gov) - P=N/A; N=0; Withdrawn; Sponsor: City of Hope Medical Center; N=148 ➔ 0; Active, not recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • Hematological Disorders • Hemophilia • Rare Diseases

A Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Von Willebrand Disease. (clinicaltrials.gov) - P2; N=N/A; Completed; Sponsor: Bio Products Laboratory; Not yet recruiting -> Completed

Trial completion • Biosimilar • Hemophilia

Plasma derived FVIII ITI outcomes in two children with hemophilia A and high titer inhibitors (EAHAD 2019) - "He switched to pdFVIII (Optivate) a year later and on a dose of 100 iu/kg twice daily, the inhibitor titer reduced to 69 BU/mL and 14 months later he received a course of Rituximab. We have seen positive outcomes with pdFVIII (Optivate) ITI in both our patients with poor prognostic markers for ITI success. Whilst our first patient was ITI naïve and attained complete tolerance on first attempt, our second patient received rescue ITI resulting in significant reduction in breakthrough bleeding."

Clinical