This trial looks at the safety and efficacy of a new drug, HEMLIBRA®, given to infants and children with hemophilia A.
6 Primary · 11 Secondary · Reporting Duration: Weekly for 4 weeks, monthly for 5 months, and every 3 months until study end (up to 36 months)
Awards & Highlights
2 Treatment Groups
Untreated/minimally treated moderate HA no inhibitors
1 of 2
Treated any moderate HA with existing inhibitors
1 of 2
60 Total Participants · 2 Treatment Groups
Primary Treatment: HEMLIBRA · No Placebo Group · Phase 3
Who is running the clinical trial?
Age < 65 · All Participants · 10 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
Frequently Asked Questions
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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)." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor