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Coagulation Factor Replacement Therapy

Eloctate ITI plus Emicizumab for Hemophilia A

Phase 3
Waitlist Available
Led By Margaret V Ragni, MD, MPH
Research Sponsored by Margaret Ragni
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male adults or children > 4 months of age.
Severe hemophilia A (FVIII < 0.01 U/ml).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights

Study Summary

This trial is testing whether a new combination therapy can eradicate inhibitors (a protein that prevents clotting) in people with severe hemophilia A.

Eligible Conditions
  • Hemophilia A

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Inhibitor Eradication
Secondary outcome measures
FVIII Mutation
FVIII Trough Level
Human Leukocyte Antigen (HLA) Haplotype
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Eloctate ITI plus EmicizumabExperimental Treatment2 Interventions
Arm A: Eloctate 100 IU/kg every other day by intravenous infusion plus Emicizumab 1.5 mg/kg subcutaneously (following 3 mg/kg/wk x 4 induction) in children and adults with severe hemophilia A and anti-FVIII inhibitor, continued up to 48 weeks.
Group II: Eloctate ITIActive Control1 Intervention
Arm B: Eloctate 100 IU/kg every other day by intravenous infusion in children and adults with severe hemophilia A and anti-FVIII inhibitor, continued up to 48 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Emicizumab
2016
Completed Phase 4
~620

Find a Location

Who is running the clinical trial?

Margaret RagniLead Sponsor
6 Previous Clinical Trials
67 Total Patients Enrolled
2 Trials studying Hemophilia A
1 Patients Enrolled for Hemophilia A
Health Resources and Services Administration (HRSA)FED
84 Previous Clinical Trials
151,341 Total Patients Enrolled
1 Trials studying Hemophilia A
1 Patients Enrolled for Hemophilia A
Margaret V Ragni, MD, MPHPrincipal InvestigatorUniversity of Pittsburgh
5 Previous Clinical Trials
60 Total Patients Enrolled
2 Trials studying Hemophilia A
1 Patients Enrolled for Hemophilia A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~0 spots leftby Mar 2025