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Monoclonal Antibodies

Emicizumab for Hemophilia A (HAVEN 4 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 5, 9, 13, 17, 21, and 25, and every 12 weeks thereafter until study completion (up to 5 years, 5 months)
Awards & highlights

HAVEN 4 Trial Summary

This trial will study whether a new medication is effective and safe for people with hemophilia A, with or without inhibitors against factor VIII. The study consists of 2 parts: a pharmacokinetic (PK) run-in part followed by an expansion part.

HAVEN 4 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 5, 9, 13, 17, 21, and 25, and every 12 weeks thereafter until study completion (up to 5 years, 5 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 5, 9, 13, 17, 21, and 25, and every 12 weeks thereafter until study completion (up to 5 years, 5 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
Bleeding time procedure
Expansion Part: Annualized Bleeding Rate (ABR) for Treated Bleeds
Bleeding time procedure
+2 more
Secondary outcome measures
Expansion Part: Change From Baseline to Week 25 in the EQ-5D-5L Questionnaire Index Utility Score
Expansion Part: Change From Baseline to Week 25 in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Questionnaire Visual Analogue Scale (VAS) Score
Expansion Part: Change From Baseline to Week 25 in the Haem-A-QoL Questionnaire Physical Health Score for Adult Participants (≥18 Years of Age)
+40 more

Side effects data

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

HAVEN 4 Trial Design

2Treatment groups
Experimental Treatment
Group I: Emicizumab: PK Run-in CohortExperimental Treatment1 Intervention
Participants received emicizumab subcutaneously (SC) at a dose of 6 mg/kg once every 4 weeks, with no loading dose, for at least 24 weeks.
Group II: Emicizumab: Expansion CohortExperimental Treatment1 Intervention
Participants received emicizumab subcutaneously (SC) at a loading dose of 3 mg/kg once every week for the first 4 weeks followed by a maintenance dose of 6 mg/kg emicizumab SC once every 4 weeks for at least 24 weeks.
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
2,430 Previous Clinical Trials
1,089,642 Total Patients Enrolled
13 Trials studying Hemophilia A
1,328 Patients Enrolled for Hemophilia A
Chugai PharmaceuticalIndustry Sponsor
95 Previous Clinical Trials
21,656 Total Patients Enrolled
3 Trials studying Hemophilia A
353 Patients Enrolled for Hemophilia A
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,964 Total Patients Enrolled
14 Trials studying Hemophilia A
1,295 Patients Enrolled for Hemophilia A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Emicizumab Given Every 4 Weeks in Participants With Hemophilia A
2017. "A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Emicizumab Given Every 4 Weeks in Participants With Hemophilia A". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03020160.
~6 spots leftby Apr 2025
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