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Monoclonal Antibodies

Emicizumab for Hemophilia A (Beyond ABR Trial)

Phase 4
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of severe congenital hemophilia A (intrinsic factor VIII [FVIII] level <1%) or moderate congenital hemophilia A (intrinsic FVIII level ≤5%) if previously prescribed prophylaxis
Must not have
Participants that plan to have joint replacement, joint procedure, synovectomy or synoviorthesis at screening
Known HIV infection not controlled by medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Summary

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.

Who is the study for?
This trial is for individuals aged 13-69 with severe or moderate Hemophilia A without Factor VIII inhibitors. They must have no history of FVIII inhibitory antibodies in the last 5 years, adequate organ function, and agree to use contraception if applicable. Excluded are those planning major joint procedures, with uncontrolled diseases like cardiovascular issues or HIV not managed by medication, or who've had certain treatments that might interfere with the study.
What is being tested?
The trial is testing Emicizumab prophylaxis on overall health, physical activity, and joint outcomes in participants. It's an open-label Phase IV study where all participants receive Emicizumab to see how it affects their condition compared to previous standard treatments they were receiving.
What are the potential side effects?
Emicizumab may cause injection site reactions, headaches, fatigue, muscle pain. Rare but serious side effects include blood clots and allergic reactions. Participants will be monitored closely for any adverse effects throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have severe or moderate hemophilia A and was on prophylaxis if moderate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am planning to undergo a joint replacement or procedure soon.
Select...
My HIV is not controlled by medication.
Select...
I have a bleeding disorder but not severe or moderate hemophilia A without previous long-term treatment.
Select...
I am scheduled for surgery during the initial phase of emicizumab treatment.
Select...
I have been treated with emicizumab before.
Select...
I have low bone density due to a significant vitamin D deficiency.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Problem Joints at 12 Months
Number of Problem Joints at 24 Months
Number of Problem Joints at 36 Months
+1 more

Side effects data

From 2022 Phase 3 trial • 48 Patients • NCT03020160
57%
ARTHRALGIA
57%
HEADACHE
43%
OSTEOARTHRITIS
43%
SYNOVITIS
29%
PHARYNGITIS
29%
CONTUSION
29%
ODYNOPHAGIA
29%
EAR INFECTION
29%
BACK PAIN
29%
UPPER RESPIRATORY TRACT INFECTION
29%
URINARY TRACT INFECTION
29%
HYPERTENSION
29%
Arthralgia
29%
Osteoarthritis
29%
Headache
29%
Upper respiratory tract infection
29%
Back pain
29%
ABDOMINAL PAIN
14%
HEAD INJURY
14%
Injection site reaction
14%
TINEA CAPITIS
14%
FALL
14%
GINGIVAL INJURY
14%
TONGUE INJURY
14%
CHEST PAIN
14%
COMPLICATION ASSOCIATED WITH DEVICE
14%
COVID-19
14%
SUBCUTANEOUS ABSCESS
14%
CHOLELITHIASIS OBSTRUCTIVE
14%
TOOTHACHE
14%
ARTHRITIS
14%
EXOSTOSIS
14%
GREATER TROCHANTERIC PAIN SYNDROME
14%
JOINT CONTRACTURE
14%
JOINT LOCK
14%
MUSCULOSKELETAL CHEST PAIN
14%
DEVICE BREAKAGE
14%
MYALGIA
14%
PARAESTHESIA
14%
MEDICAL DEVICE DISCOMFORT
14%
POST PROCEDURAL INFLAMMATION
14%
ANXIETY
14%
RASH
14%
Temporomandibular joint syndrome
14%
Post procedural inflammation
14%
INFLAMMATION
14%
INJECTION SITE REACTION
14%
Dyspepsia
14%
Device related infection
14%
Contusion
14%
Synovitis
14%
Tendon disorder
14%
Joint lock
14%
Cholelithiasis
14%
Myalgia
14%
HYPERCHOLESTEROLAEMIA
14%
VITAMIN D DEFICIENCY
14%
Abdominal pain
14%
Tongue injury
14%
Eczema eyelids
14%
Ear infection
14%
Osteitis
14%
Pharyngitis
14%
Hypertension
14%
Musculoskeletal chest pain
14%
IRON DEFICIENCY ANAEMIA
14%
ECZEMA EYELIDS
14%
DIARRHOEA
14%
DYSPEPSIA
14%
PYREXIA
14%
SEASONAL ALLERGY
14%
DEVICE RELATED INFECTION
14%
SPINAL OSTEOARTHRITIS
14%
TEMPOROMANDIBULAR JOINT SYNDROME
14%
TENDON DISORDER
14%
MOTOR DYSFUNCTION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Emicizumab: PK Run-In Cohort
Emicizumab: Expansion Cohort

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3, Hemophilia A and with Osteochondral Damage: EmicizumabExperimental Treatment1 Intervention
Cohort 3 comprises participants with severe or moderate hemophilia A and with osteochondral damage (HEAD-US bone and cartilage score of ≥1) in at least one index joint and with any synovitis score.
Group II: Cohort 2, Hemophilia A and with Synovitis Only: EmicizumabExperimental Treatment1 Intervention
Cohort 2 comprises participants with severe or moderate hemophilia A and with synovitis (HEAD-US synovitis score of ≥1) in at least one index joint and no osteochondral damage (HEAD-US bone and cartilage score of 0).
Group III: Cohort 1, Hemophilia A and Without Arthropathy: EmicizumabExperimental Treatment1 Intervention
Cohort 1 comprises participants with severe or moderate hemophilia A and with no synovitis and no osteochondral damage (Haemophilia Early Arthropathy Detection with Ultrasound \[HEAD-US\] score of 0) in all index joints.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Emicizumab
2016
Completed Phase 3
~620

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,447 Previous Clinical Trials
1,094,838 Total Patients Enrolled
13 Trials studying Hemophilia A
1,236 Patients Enrolled for Hemophilia A
Clinical TrialsStudy DirectorHoffmann-La Roche
2,217 Previous Clinical Trials
894,719 Total Patients Enrolled
14 Trials studying Hemophilia A
1,203 Patients Enrolled for Hemophilia A

Media Library

Emicizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05181618 — Phase 4
Hemophilia A Research Study Groups: Cohort 1, Hemophilia A and Without Arthropathy: Emicizumab, Cohort 2, Hemophilia A and with Synovitis Only: Emicizumab, Cohort 3, Hemophilia A and with Osteochondral Damage: Emicizumab
Hemophilia A Clinical Trial 2023: Emicizumab Highlights & Side Effects. Trial Name: NCT05181618 — Phase 4
Emicizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05181618 — Phase 4
~65 spots leftby Dec 2026
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