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Monoclonal Antibodies
Emicizumab for Hemophilia A (AHAEmi Trial)
Phase 2
Recruiting
Led By Rebecca Kruse-Jarres, MD, MPH
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥18 years at time of signing Informed Consent Form
Current bleeding due to AHA at the time of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 to 24 weeks
Awards & highlights
AHAEmi Trial Summary
This trial will test if a new medication can prevent bleeds in people with a rare blood disorder.
Who is the study for?
Adults diagnosed with acquired Hemophilia A, evidenced by reduced FVIII activity and positive FVIII inhibitor, can join this trial. They must be willing to adhere to emicizumab prophylaxis, not have used certain clotting treatments recently, and women of childbearing age should use effective contraception or abstain from sex.Check my eligibility
What is being tested?
The study is testing the effectiveness of emicizumab given regularly to prevent bleeding in patients with acquired Hemophilia A. It's a phase II trial where all participants receive the same treatment without being compared to another group.See study design
What are the potential side effects?
Emicizumab may cause injection site reactions, headaches, joint pain, and fatigue. There's also a risk for developing blood clots or an immune response that could interfere with its effectiveness.
AHAEmi Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years or older.
Select...
I am currently experiencing bleeding due to AHA.
Select...
I have been diagnosed with AHA, with specific test results.
AHAEmi Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of entire study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of entire study
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Meassure
Secondary outcome measures
Days of treatment with additional hemostatic agent
Hospitalizations
Incidence and severity of adverse events
+2 moreOther outcome measures
Comparison of historic GTH-AH 01/2020 cohort/ Number of clinically significant bleeds
Hemorrhage
AHAEmi Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental-treatmentExperimental Treatment1 Intervention
Treatment with emicizumab
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,715 Total Patients Enrolled
1 Trials studying Hemophilia A
15 Patients Enrolled for Hemophilia A
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
568,092 Total Patients Enrolled
16 Trials studying Hemophilia A
3,809 Patients Enrolled for Hemophilia A
Rebecca Kruse-Jarres, MD, MPHPrincipal InvestigatorUniversity of Washington
4 Previous Clinical Trials
78 Total Patients Enrolled
4 Trials studying Hemophilia A
78 Patients Enrolled for Hemophilia A
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years or older.I would refuse blood or blood product transfusions if needed.I haven't taken aPCC in the last 24 hours and don't plan to during the study.I have tested positive for lupus anticoagulant.I do not have a severe infection that is currently uncontrolled.I am currently experiencing bleeding due to AHA.I am currently being treated with emicizumab.I have no health conditions that make emicizumab unsafe for me.I have congenital hemophilia A.I am currently being treated for or have signs of blood clots.I have been diagnosed with AHA, with specific test results.I do not have active blood clotting disorders.I have a severe blood clotting disorder.I have had severe allergic reactions to monoclonal antibody therapies or emicizumab.I haven't taken any experimental drugs for hemophilia or other conditions recently.I am using highly effective birth control or not having sex if I can have children.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any unfilled positions for participants in this trial?
"That is correct. The clinicaltrials.gov website says this study is ongoing and currently looking for 51 participants at 1 site. This trial was first posted on 8/31/2022 and the most recent update was 9/6/2022."
Answered by AI
Has the government given their okay to emicizumab?
"Emicizumab has been evaluated in a Phase 2 trial, so there is some supporting data for its safety. However, because this drug has not yet progressed to a Phase 3 trial, the efficacy of emicizumab is still unknown."
Answered by AI
How many people fit the qualifications to participate in this research?
"Yes, according to clinicaltrials.gov, this research is still enrolling patients. This trial was first announced on 8/31/2022 and most recently updated on 9/6/2022. Right now, the study needs 51 participants from 1 location."
Answered by AI
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