← Back to Search

Monoclonal Antibodies

Emicizumab for Hemophilia A (HAVEN 7 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
Documentation of hemophilia-related treatments received since birth
Mandatory receipt of vitamin K prophylaxis according to local standard practice
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 1, 2, 3, 4, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53, and annually during the 7-year follow-up period until study completion (up to 8 years)
Awards & highlights

HAVEN 7 Trial Summary

This trial is testing a new medicine for babies with severe hemophilia A. The medicine will be given once every 2 weeks for a year, and then once a week, every 2 weeks, or every 4 weeks for 7 more years.

Who is the study for?
This trial is for babies from birth to 12 months with severe Hemophilia A (FVIII level <1%) without inhibitors. They must be previously untreated or minimally treated, weigh at least 3 kg, have no history of FVIII inhibitor or thrombotic disease, and not be infected with HIV or hepatitis. Parents must commit to the study's requirements.Check my eligibility
What is being tested?
The study tests Emicizumab's effectiveness and safety in preventing bleeding episodes in young children with Hemophilia A. It involves a weekly injection for one year followed by a long-term follow-up period where dosage frequency may vary.See study design
What are the potential side effects?
Potential side effects include reactions at the injection site, headaches, joint pain, general discomfort, and possibly an increased risk of developing blood clots or experiencing abnormal bleeding.

HAVEN 7 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have records of all hemophilia treatments I've received since birth.
Select...
I have received vitamin K as per local health guidelines.
Select...
I have severe hemophilia A with very low factor VIII levels.
Select...
I don't have a history of FVIII inhibitor, my FVIII lasts over 6 hours, and recovers well.
Select...
I am a baby aged 12 months or younger.

HAVEN 7 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 1, 2, 3, 4, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53, and annually during the 7-year follow-up period until study completion (up to 8 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 1, 2, 3, 4, 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, and 53, and annually during the 7-year follow-up period until study completion (up to 8 years) 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 Bleeding Rate for All Bleeds
Mean Calculated Annualized Bleeding Rate for Treated Bleeds
Mean Calculated Annualized Bleeding Rate for Treated Joint Bleeds
+9 more
Secondary outcome measures
Change from Baseline in Body Temperature Over Time
Change from Baseline in Diastolic Blood Pressure Over Time
Change from Baseline in Pulse Rate Over Time
+14 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%
BACK PAIN
29%
UPPER RESPIRATORY TRACT INFECTION
29%
URINARY TRACT INFECTION
29%
HYPERTENSION
29%
Arthralgia
29%
Osteoarthritis
29%
Headache
29%
ODYNOPHAGIA
29%
Upper respiratory tract infection
29%
Back pain
29%
ABDOMINAL PAIN
29%
EAR INFECTION
14%
EXOSTOSIS
14%
JOINT CONTRACTURE
14%
MUSCULOSKELETAL CHEST PAIN
14%
MYALGIA
14%
SUBCUTANEOUS ABSCESS
14%
CHOLELITHIASIS OBSTRUCTIVE
14%
JOINT LOCK
14%
DEVICE BREAKAGE
14%
TINEA CAPITIS
14%
PARAESTHESIA
14%
ARTHRITIS
14%
FALL
14%
GREATER TROCHANTERIC PAIN SYNDROME
14%
CHEST PAIN
14%
HEAD INJURY
14%
GINGIVAL INJURY
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%
TOOTHACHE
14%
COMPLICATION ASSOCIATED WITH DEVICE
14%
TONGUE INJURY
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%
COVID-19
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 7 Trial Design

1Treatment groups
Experimental Treatment
Group I: EmicizumabExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Emicizumab
2016
Completed Phase 4
~620

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,426 Previous Clinical Trials
1,089,077 Total Patients Enrolled
13 Trials studying Hemophilia A
1,321 Patients Enrolled for Hemophilia A
Clinical TrialsStudy DirectorHoffmann-La Roche
2,197 Previous Clinical Trials
888,505 Total Patients Enrolled
14 Trials studying Hemophilia A
1,288 Patients Enrolled for Hemophilia A

Media Library

Emicizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04431726 — Phase 3
Hemophilia A Research Study Groups: Emicizumab
Hemophilia A Clinical Trial 2023: Emicizumab Highlights & Side Effects. Trial Name: NCT04431726 — Phase 3
Emicizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04431726 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for this clinical trial?

"The trial is no longer looking for patients as of September 6th, 2022. The study was first posted on February 4th, 2021 and was last edited on the date mentioned above. If you are hoping to join another clinical trial, 91 trials for hemophilia A and 9 trials for Emicizumab are still recruiting participants."

Answered by AI

What other research exists on Emicizumab's effects?

"Currently, 9 Emicizumab trials are underway. Of these live studies, 5 have progressed to Phase 3. Although the majority of research is being conducted in Dallas, Texas; 148 total locations are running clinical trials for this medication."

Answered by AI

How do I sign up for this clinical trial?

"This trial is currently looking for 55 infants that suffer from hemophilia A. These participants must be between 0-12 months old and meet the following conditions: a lack of significant exposure to prior treatments (i.e. up to 5 days with blood plasma products, fresh frozen plasma, cryoprecipitate, or whole blood), as well as documentation of all bleeding episodes since birth."

Answered by AI

If an person is not yet 40 years old, can they participate in this particular research study?

"This study includes infants that are 0 months old up to toddlers that are 12 months old."

Answered by AI

Does this type of research procedure have a precedent?

"Emicizumab has been under scientific scrutiny since 2018. The first clinical trial, sponsored by Hoffmann-La Roche, was completed that year and involved 85 patients. Following the success of that initial study, Emicizumab received Phase 3 drug approval in 2018. Currently, there are 9 live trials for Emicizumab taking place in 56 cities across 22 different countries."

Answered by AI

Are there any life-threatening risks associated with Emicizumab?

"Given that this is a Phase 3 trial with some efficacy data and multiple rounds of safety data, our team has given Emicizumab a score of 3 for safety."

Answered by AI
~13 spots leftby Mar 2025