Trial intelligence / Profile preview

IMMUNATE S/D in Hemophilia A

NCT00162019Phase 3

Key facts

Status: Completed
Start: Mar 2003
Primary completion: Aug 2004
Countries: 4
Sponsor: Takeda
Modality: Recombinant Proteins and Enzymes

Drugs: Immunate
Conditions: hemophilia A

Overview

Phase 3, open-label, single-arm trial of Immunate in hemophilia A, sponsored by Takeda. Primary endpoints: Pharmacokinetic parameters of IMMUNATE S/D and IMMUNATE, Re-evaluation of PK parameters for IMMUNATE S/D and 4 more. Started Mar 2003; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

IMMUNATE S/D
Patients receiving IMMUNATE S/D for PK and treatment of bleeding episodes.

Who it enrols

Previously treated male patients (>= 150 exposure days) with severe or moderately severe Hemophilia A, aged 12-65 years, with no history of inhibitors.

Endpoints

Primary

Pharmacokinetic parameters of IMMUNATE S/D and IMMUNATE0-48 hours post-infusion
Re-evaluation of PK parameters for IMMUNATE S/DAfter 14 weeks or 10 EDs
Incidence of factor VIII inhibitor development27 weeks or 50 EDs
Hemostatic efficacy in bleeding episodes and surgical prophylaxis27 weeks or 50 EDs
Clinical safety of IMMUNATE S/D18 months

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