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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 belowSelect...
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 weeks3 visits
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)
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)
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 moreSecondary 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 moreSide effects data
From 2022 Phase 3 trial • 48 Patients • NCT0302016057%
ARTHRALGIA
57%
HEADACHE
43%
OSTEOARTHRITIS
43%
SYNOVITIS
29%
ODYNOPHAGIA
29%
CONTUSION
29%
BACK PAIN
29%
PHARYNGITIS
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%
COVID-19
14%
GREATER TROCHANTERIC PAIN SYNDROME
14%
TOOTHACHE
14%
MYALGIA
14%
COMPLICATION ASSOCIATED WITH DEVICE
14%
CHOLELITHIASIS OBSTRUCTIVE
14%
SUBCUTANEOUS ABSCESS
14%
JOINT CONTRACTURE
14%
HEAD INJURY
14%
DEVICE BREAKAGE
14%
TONGUE INJURY
14%
JOINT LOCK
14%
MUSCULOSKELETAL CHEST PAIN
14%
FALL
14%
EXOSTOSIS
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 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 3
~620
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,434 Previous Clinical Trials
1,091,337 Total Patients Enrolled
13 Trials studying Hemophilia A
1,321 Patients Enrolled for Hemophilia A
Clinical TrialsStudy DirectorHoffmann-La Roche
2,202 Previous Clinical Trials
889,981 Total Patients Enrolled
14 Trials studying Hemophilia A
1,288 Patients Enrolled for Hemophilia A
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe bleeding, like a brain bleed.I have a genetic or acquired condition that increases my risk of blood clots.I have records of all hemophilia treatments I've received since birth.I have a condition that increases my risk of bleeding or blood clots.I am not planning any major surgeries during the study.I have not taken certain medications recently.I have a bleeding disorder that is not severe hemophilia A.I am at high risk for blood clotting disorders.I am not using, nor plan to use, immune system altering drugs during the study.I have not had a serious infection needing antibiotics or antivirals in the last 14 days.I have not received much or any treatment for my condition.I don't have any health issues that could affect my participation or safety in the study.My body weight is at least 3 kilograms.I have received vitamin K as per local health guidelines.I have severe hemophilia A with very low factor VIII levels.My baby has no signs of active bleeding in the brain.I don't have a history of FVIII inhibitor, my FVIII lasts over 6 hours, and recovers well.I have been treated for blood clots before.I am a baby aged 12 months or younger.I am not willing to receive blood products or standard treatments.My blood, liver, and kidney functions meet the required levels.
Research Study Groups:
This trial has the following groups:- Group 1: Emicizumab
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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