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Hemlibra in Mild Hemophilia A

NCT04567511 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-03-15

No results posted yet for this study

Summary

This is a single arm, phase 4, prospective, open-label, United States single-center study to determine the hemostatic characteristics of Hemlibra (emicizumab) as measured by coagulation laboratory parameters in the mild hemophilia A male patient population with endogenous altered FVIII (baseline FVIII activity of \>5% to 30%). The safety and hemostatic efficacy of Hemlibra (emicizumab) in this patient population will be investigated. Secondary outcomes will assess changes in joint health and quality of life in treated patients.

Conditions

  • Factor VIII Deficiency, Congenital

Interventions

DRUG

Emicizumab

bispecific monoclonal antibody binding to activated Factor IX and Factor X

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Indiana Hemophilia &Thrombosis Center, Inc.

    lead OTHER

Principal Investigators

  • Amy D Shapiro, MD · Indiana Hemophilia &Thrombosis Center, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-25
Primary Completion
2025-07-31
Completion
2027-07-31
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 NCT04567511 on ClinicalTrials.gov