Trial intelligence / Profile preview

INITIATE: Individualized ITI with Wilate

NCT03204539Phase 4

Key facts

Status: Terminated
Start: Jun 2017
Primary completion: Jul 2019
Countries: 1
Sponsor: University of California, Davis
Modality: Recombinant Proteins and Enzymes

Drugs: von Willebrand factor concentrate
Conditions: hemophilia A

Overview

Phase 4, randomised, double-blind trial of von Willebrand factor concentrate in hemophilia A (2 arms), sponsored by University of California, Davis. Primary endpoint: Time to Negative Inhibitor at 18 months. Started Jun 2017; status: terminated.

Design

2 arms

Study design: RandomizedDouble-blind

Alternative Treatment
Individualized lot selection of Wilate
Standard Treatment
Random lot selection of Wilate

Who it enrols

Patients with congenital Hemophilia A, FVIII activity <=2%, and a historical high-titer inhibitor (>=5 BU).

Endpoints

Primary

Time to Negative Inhibitor18 months

Secondary

Time to Achieve Partial and Complete Success18 months
Absence of Relapse30 months
The Number of Break-through Bleeding Events18 months
Cost of ITI18 months
Subject Quality of Life18 months
Subject Compliance With ITI Treatment Regimen18 months

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