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The Hemophilia Inhibitor Prevention Trial

NCT04303559 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-04-11

Study results available
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Summary

This is a multi-center randomized phase III clinical trial, the Inhibitor Prevention Trial, in which Eloctate will be compared with Emicizumab, using adaptive design, to prevent inhibitors in patients with severe hemophilia A.

Conditions

  • Hemophilia A Without Inhibitor

Interventions

DRUG

Eloctate Injectable Product

This is a factor VIII-Fc fusion protein.

DRUG

Emicizumab Injection [Hemlibra]

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
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Months
Max Age
4 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-11
Primary Completion
2022-04-06
Completion
2022-06-16
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 NCT04303559 on ClinicalTrials.gov