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Monoclonal Antibodies
HEMLIBRA for Hemophilia A
Phase 3
Waitlist Available
Led By Robert Sidonio, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weekly for 4 weeks, monthly for 5 months, and every 3 months until study end (up to 36 months)
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial tests the safety and effectiveness of HEMLIBRA® combined with a small dose of NUWIQ® in young children with Hemophilia A. It aims to prevent bleeding and reduce the risk of developing inhibitors, making treatment easier and more effective. Emicizumab (Hemlibra) is approved for treating hemophilia A and has been shown to significantly reduce bleeding rates.
Eligible Conditions
- Hemophilia A
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weekly for 4 weeks, monthly for 5 months, and every 3 months until study end (up to 36 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weekly for 4 weeks, monthly for 5 months, and every 3 months until study end (up to 36 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cumulative incidence of inhibitors to FVIII
Number of Immune Tolerance Induction (ITI) failure cases
Number of Immune Tolerance Induction (ITI) partial failure cases
+3 moreSecondary study objectives
Annualized bleeding rate (ABR)
Change in Adapted Inhib-QoL scale score
Change in CATCH scale score
+9 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Untreated/minimally treated moderate HA no inhibitorsExperimental Treatment2 Interventions
Previously untreated patients (PUPs) and minimally treated patients (MTPs) \<3 years of age with moderately severe (≤2% FVIII) HA and no inhibitors.
Group II: Treated any moderate HA with existing inhibitorsExperimental Treatment2 Interventions
Children \<21 years of age with moderately severe (≤2% FVIII) HA and with already existing inhibitors (LTI or HTI).
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Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,555 Previous Clinical Trials
569,363 Total Patients Enrolled
16 Trials studying Hemophilia A
3,860 Patients Enrolled for Hemophilia A
Emory UniversityLead Sponsor
1,696 Previous Clinical Trials
2,603,741 Total Patients Enrolled
7 Trials studying Hemophilia A
186 Patients Enrolled for Hemophilia A
Robert Sidonio, MDPrincipal InvestigatorEmory University
2 Previous Clinical Trials
128 Total Patients Enrolled
1 Trials studying Hemophilia A
20 Patients Enrolled for Hemophilia A
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your kidneys are working well enough (based on certain tests) to participate in the study.You have moderately severe hemophilia A, which means you have very low levels of clotting factor VIII (less than or equal to 2%).You are under 3 years old when you give your permission to participate.Your liver is working well. Your bilirubin levels and AST/ALT levels are within a certain range.You have received two or fewer treatments of certain blood products such as pdFVIII, rFVIII, FFP, Cryoprecipitate, or PRBCs.You have not developed antibodies against FVIII since you were born. You may also participate in the ATHN 8 study.You have enough healthy blood cells (hemoglobin level above 8 g/dL and platelet count above 100,000 µL).The person taking care of you (parent or legal guardian) has given written permission for you to participate in the study.Requirements to be eligible for Part B of the study.You must have a test to confirm that there is no inhibitor in your blood within four weeks of joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: Untreated/minimally treated moderate HA no inhibitors
- Group 2: Treated any moderate HA with existing inhibitors
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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