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The Hemophilia Inhibitor Eradication Trial

NCT04303572 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-02-21

Study results available
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Summary

This is a multi-center randomized phase III clinical trial, the Inhibitor Eradication Trial, in which Eloctate ITI plus Emicizumab will be compared with Eloctate ITI alone to eradicate inhibitors in severe hemophilia A.

Conditions

  • Hemophilia A With Inhibitor

Interventions

DRUG

Eloctate ITI

This is a factor VIII-Fc infusion protein.

DRUG

Emicizumab

This is a bispecific monoclonal antibody FVIII mimic.

Sponsors & Collaborators

  • Health Resources and Services Administration (HRSA)

    collaborator FED

  • Margaret Ragni

    lead OTHER

Principal Investigators

  • Margaret V Ragni, MD, MPH · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2022-06-27
Completion
2022-06-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04303572 on ClinicalTrials.gov