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HemLibra Prophylaxis in Patients With Hemophilic Pseudotumor

NCT03921294 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2024-04-11

Study results available
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Summary

This is a single arm, phase 4, prospective, open-label, United States single-center study to assess the hemostatic efficacy and safety of Hemlibra (emicizumab) for hemostatic control of hemophilia A patients (baseline FVIII level \<40%) with and without inhibitors with hemophilic pseudotumors; secondary outcomes will assess changes in quality of life and activity level in treated patients.

Conditions

  • Haemophilic Pseudotumour

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

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-15
Primary Completion
2022-03-16
Completion
2022-03-16
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 NCT03921294 on ClinicalTrials.gov