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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

Study Summary

This trial looks at the safety and efficacy of a new drug, HEMLIBRA®, given to infants and children with hemophilia A.

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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly for 4 weeks, monthly for 5 months, and every 3 months until study end (up to 36 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cumulative incidence of inhibitors to FVIII
Number of Immune Tolerance Induction (ITI) failure cases
Number of Immune Tolerance Induction (ITI) partial failure cases
+3 more
Secondary outcome measures
Annualized bleeding rate (ABR)
Change in Adapted Inhib-QoL scale score
Change in CATCH scale score
+9 more

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).

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
567,689 Total Patients Enrolled
16 Trials studying Hemophilia A
3,860 Patients Enrolled for Hemophilia A
Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,573 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

HEMLIBRA (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04030052 — Phase 3
Hemophilia A Research Study Groups: Untreated/minimally treated moderate HA no inhibitors, Treated any moderate HA with existing inhibitors
Hemophilia A Clinical Trial 2023: HEMLIBRA Highlights & Side Effects. Trial Name: NCT04030052 — Phase 3
HEMLIBRA (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04030052 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you walk me through the other scientific research that has been conducted on HEMLIBRA?

"There are 20 ongoing clinical trials for HEMLIBRA, with 8 of them in Phase 3. The primary location for these studies is Nimes, Maryland; however, there are a total of 452 locations running HEMLIBRA trials."

Answered by AI

At how many separate venues is this research project being undertaken?

"Currently, this study is being conducted out of Rush University Medical Center in Chicago, Illinois; Verisiti, WI in Milwaukee, Wisconsin; and University of North carolina - Hemophilia and Thrombosis Center in Chapel Hill, North Carolina. There are also 8 other locations where this trial is taking place."

Answered by AI

Are there any more room in this clinical trial for new patients?

"The study is currently looking for participants, as stated on clinicaltrials.gov. This particular clinical trial was first posted on February 17th, 2022 and was edited more recently on the 21st of the same month."

Answered by AI

HEMLIBRA has been approved for what condition(s)?

"HEMLIBRA is indicated for the treatment of parenteral drug administration. It may also be used off-label to treat conditions like bleeding and hemophilia A."

Answered by AI

How many human subjects are participating in this research?

"In order to proceed with the trial, a total of 60 eligible patients are needed. The clinical research will be conducted by Genentech, Inc. at various sites; two examples include Rush University Medical Center (Chicago, Illinois) and Verisiti (Milwaukee, Wisconsin)."

Answered by AI

Could you please tell me the risks associated with HEMLIBRA?

"HEMLIBRA's safety has been well studied in prior Phase 3 clinical trials, so it received a score of 3."

Answered by AI

What is the significance of this research?

"The primary outcome that will be measured over the course of this 36 month follow-up interval is the cumulative incidence of FVIII inhibitors. However, other important data points that will be collected include change in blood levels of emicizumab (HEMLIBRA®), anti-emicizumab antibodies, and adapted Inhib-QoL scale score."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Emicizumab PUPs and Nuwiq ITI Study
Robert Sidonio 2022. "Emicizumab PUPs and Nuwiq ITI Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04030052.
~0 spots leftby Apr 2025
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