This trial will look at the effect of a new drug, emicizumab, on people with severe hemophilia A. The goal is to see if it improves overall health, physical activity, and joint outcomes.
- Hemophilia A
- Moderate Hemophilia A
- Severe Hemophilia A
28 Primary · 7 Secondary · Reporting Duration: From Baseline until 24 weeks after the final dose of emicizumab (up to 3.5 years)
Side Effects for
3 Treatment Groups
Cohort 2, Hemophilia A and with Synovitis Only: Emicizumab
1 of 3
Cohort 1, Hemophilia A and Without Arthropathy: Emicizumab
1 of 3
Cohort 3, Hemophilia A and with Osteochondral Damage: Emicizumab
1 of 3
120 Total Participants · 3 Treatment Groups
Primary Treatment: Emicizumab · No Placebo Group · Phase 4
Who is running the clinical trial?
Age 13 - 69 · All Participants · 6 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
Who else is applying?
What state do they live in?
How old are they?
|18 - 65||100.0%|
What site did they apply to?
|Hemostasis & Thrombosis Center of Nevada (HTCNV)||100.0%|
What portion of applicants met pre-screening criteria?
Frequently Asked Questions
Is this an innovative exploration into treatments?
"Currently, there are 9 ongoing trials of Emicizumab spanning 22 countries and 56 cities. The pioneering research on the drug was completed by Hoffmann-La Roche in 2018 with 85 participants. Since then, a further 7 studies were conducted to support its Phase 3 drug approval status." - Anonymous Online Contributor
Has the FDA accepted Emicizumab for clinical use?
"Emicizumab's safety has been approved by Phase 4 trials, so it was awarded a rating of 3." - Anonymous Online Contributor
What is the scale of recruitment for this experiment?
"Hoffmann-La Roche is administering this trial with the aim of recruiting 120 patients that meet the criteria. The study will be conducted from two different sites, Oklahoma Children's Hospital - Jimmy Everest Center in Las Vegas and Hemostasis & Thrombosis Center of Nevada (HTCNV) located in Coral Gables." - Anonymous Online Contributor
Is enrollment still available for the study?
"Affirmative. According to clinicaltrials.gov, this research trial launched on June 20th 2022 and is currently enrolling subjects. Seven sites are collaborating in the attempt to recruit 120 individuals for participation." - Anonymous Online Contributor
What criteria must prospective participants fulfill to be eligible for this clinical trial?
"This study seeks 120 individuals suffering from hemophilia A, aged 13 to 69 years old. Most importantly, applicants must meet the following conditions: diagnosed with severe (FVIII <1%) or moderate (FVIII ≤5%) congenital haemophilia; no inhibitor in last 5 yrs.; successful immune tolerance induction at least 5 yr prior w/o recurrence of inhibitors; stable FVIII prophylaxis for min 24 weeks before entry; adequate hematologic, hepatic & renal functions and women of childbearing potential agree to contraception or abstinence during emicizumab treatment period + 24 weeks after" - Anonymous Online Contributor
Does the current research include any participants above the age of seventy-five?
"This trial requires potential participants to be between 13 and 69 years old." - Anonymous Online Contributor
How many healthcare facilities are facilitating this clinical trial?
"Participants can join this experiment at Oklahoma Children's Hospital - Jimmy Everest Center in Las Vegas, Hemostasis & Thrombosis Center of Nevada (HTCNV) in Coral Gables, or University of Miami in New Hyde Park. In addition to these three sites, there are 7 other enrolment hubs across the country." - Anonymous Online Contributor
What other empirical investigations have been conducted involving Emicizumab?
"Since its initial research at Xiangya Hospital of Centre-South University in 2018, emicizumab has been subject to 7 completed clinical trials. Additionally, there are currently 9 active studies taking place with numerous sites located within the Las Vegas area of Nevada." - Anonymous Online Contributor