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Monoclonal Antibodies

Emicizumab for Hemophilia A (HAVEN 6 Trial)

Phase 3
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 mild (FVIII level between >5% and <40%) or moderate (FVIII level between ≥1% and ≤5%) congenital Hemophilia A without FVIII inhibitors
Must not have
Inherited or acquired bleeding disorder other than mild or moderate congenital hemophilia A
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-dose at weeks 1, 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, and 49, and every 12 weeks thereafter until study completion/discontinuation (up to approximately 48 months)
Awards & highlights

Summary

This trial will assess a new medication for people with hemophilia A who don't have inhibitors against factor VIII. The study will measure how safe and effective the drug is, as well as how it is metabolized and impacts the body.

Who is the study for?
This trial is for individuals with mild or moderate Hemophilia A without inhibitors to factor VIII. Participants must weigh at least 3 kg, need prophylaxis, have documented treatment and bleeding episodes history, and proper organ function. Women of childbearing age should agree to use contraception.Check my eligibility
What is being tested?
The study tests Emicizumab's safety, effectiveness, how the body processes it (pharmacokinetics), and its impact on the body (pharmacodynamics) in those with mild/moderate Hemophilia A who don't have FVIII inhibitors.See study design
What are the potential side effects?
Potential side effects of Emicizumab may include reactions at the injection site, headaches, fatigue, muscle pain. Since it's designed for people with hemophilia, there might be a risk of developing antibodies against the drug that could reduce its effectiveness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have mild or moderate Hemophilia A without inhibitors.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a bleeding disorder that is not mild or moderate hemophilia A.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-dose at weeks 1, 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, and 49, and every 12 weeks thereafter until study completion/discontinuation (up to approximately 48 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose at weeks 1, 2, 3, 4, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, and 49, and every 12 weeks thereafter until study completion/discontinuation (up to approximately 48 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
Mean Calculated Annualized Bleed Rate for Treated Bleeds
Median Calculated Annualized Bleed Rate for Treated Bleeds
Model-Based Annualized Bleed Rate for Treated Bleeds
Secondary outcome measures
CATCH Questionnaire for Adult Participants: Change From Baseline in the Daily Activity Risk Perception and Impact Domain Scores Over Time
CATCH Questionnaire for Adult Participants: Change From Baseline in the Preoccupation Domain Score Over Time
CATCH Questionnaire for Adult Participants: Change From Baseline in the Recreational Activity Risk Perception and Impact Domain Scores Over Time
+58 more

Side effects data

From 2022 Phase 3 trial • 48 Patients • NCT03020160
57%
ARTHRALGIA
57%
HEADACHE
43%
OSTEOARTHRITIS
43%
SYNOVITIS
29%
BACK PAIN
29%
EAR INFECTION
29%
ODYNOPHAGIA
29%
CONTUSION
29%
PHARYNGITIS
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%
EXOSTOSIS
14%
MUSCULOSKELETAL CHEST PAIN
14%
DEVICE BREAKAGE
14%
MYALGIA
14%
COMPLICATION ASSOCIATED WITH DEVICE
14%
TINEA CAPITIS
14%
GINGIVAL INJURY
14%
HEAD INJURY
14%
COVID-19
14%
CHOLELITHIASIS OBSTRUCTIVE
14%
TOOTHACHE
14%
SUBCUTANEOUS ABSCESS
14%
TONGUE INJURY
14%
ARTHRITIS
14%
CHEST PAIN
14%
FALL
14%
GREATER TROCHANTERIC PAIN SYNDROME
14%
JOINT CONTRACTURE
14%
JOINT LOCK
14%
PARAESTHESIA
14%
Injection site reaction
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

1Treatment groups
Experimental Treatment
Group I: EmicizumabExperimental Treatment1 Intervention
Participants with mild and moderate hemophilia A without factor VIII (FVIII) inhibitors will be enrolled to receive the emicizumab loading dose regimen followed by the participant's preference of one of 3 maintenance dose regimens.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Emicizumab
2016
Completed Phase 3
~620

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Hemophilia A include factor replacement therapy, gene therapy, and newer agents like Emicizumab. Factor replacement therapy involves infusing the missing factor VIII directly into the bloodstream to aid in blood clotting. Gene therapy introduces functional genes to produce the missing clotting factor. Emicizumab, a bispecific monoclonal antibody, bridges activated factor IX and factor X to promote blood clotting, offering a different approach by mimicking the function of factor VIII. These treatments are essential for Hemophilia A patients as they help manage bleeding episodes, reduce the frequency of bleeding, and improve overall quality of life.

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,436 Previous Clinical Trials
1,091,562 Total Patients Enrolled
13 Trials studying Hemophilia A
1,303 Patients Enrolled for Hemophilia A
Clinical TrialsStudy DirectorHoffmann-La Roche
2,204 Previous Clinical Trials
890,233 Total Patients Enrolled
14 Trials studying Hemophilia A
1,270 Patients Enrolled for Hemophilia A

Media Library

Emicizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04158648 — Phase 3
Hemophilia A Research Study Groups: Emicizumab
Hemophilia A Clinical Trial 2023: Emicizumab Highlights & Side Effects. Trial Name: NCT04158648 — Phase 3
Emicizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04158648 — Phase 3
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