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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
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
HAVEN 6 Trial 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.
HAVEN 6 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have mild or moderate Hemophilia A without inhibitors.
HAVEN 6 Trial Timeline
Screening ~ 3 weeks3 visits
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)
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)
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 moreSide effects data
From 2022 Phase 3 trial • 48 Patients • NCT0302016057%
ARTHRALGIA
57%
HEADACHE
43%
OSTEOARTHRITIS
43%
SYNOVITIS
29%
CONTUSION
29%
ODYNOPHAGIA
29%
PHARYNGITIS
29%
BACK PAIN
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%
COVID-19
14%
JOINT CONTRACTURE
14%
MYALGIA
14%
TONGUE INJURY
14%
TOOTHACHE
14%
COMPLICATION ASSOCIATED WITH DEVICE
14%
SUBCUTANEOUS ABSCESS
14%
FALL
14%
HEAD INJURY
14%
EXOSTOSIS
14%
JOINT LOCK
14%
MUSCULOSKELETAL CHEST PAIN
14%
GREATER TROCHANTERIC PAIN SYNDROME
14%
DEVICE BREAKAGE
14%
CHEST PAIN
14%
ARTHRITIS
14%
TINEA CAPITIS
14%
CHOLELITHIASIS OBSTRUCTIVE
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 6 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
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,981 Total Patients Enrolled
13 Trials studying Hemophilia A
1,303 Patients Enrolled for Hemophilia A
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,429 Total Patients Enrolled
14 Trials studying Hemophilia A
1,270 Patients Enrolled for Hemophilia A
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have mild or moderate Hemophilia A without inhibitors.I weigh at least 3 kilograms.I am not planning any surgery during the initial phase of my emicizumab treatment.My blood, liver, and kidney functions are all within normal ranges.I have records of my bleeding episodes and Factor VIII treatment for the last 6 months.You have had a serious allergic reaction to monoclonal antibody treatments or any ingredients in the emicizumab injection.I have not taken any experimental drugs recently, except for emicizumab for hemophilia.I don't have any health issues that could affect the study or make it unsafe for me.You have had a problem with using illegal drugs or drinking too much alcohol in the past year, according to the doctor's opinion.I have been treated for or shown signs of blood clots in the last year.I do not have conditions that increase my risk of bleeding or blood clots.I have a bleeding disorder that is not mild or moderate hemophilia A.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new patients being welcomed into this research project at this time?
"The most recent update on clinicaltrials.gov indicates that this trial is not currently looking for new patients. The study was first posted on February 10th 2020 and updated August 2nd 2022. However, there are many other opportunities to participate in medical research, as there are 110 other trials recruiting at this moment."
Answered by AI
Has Emicizumab been cleared by the FDA?
"Emicizumab has been evaluated for safety in Phase 3 trials, which means that there is some evidence to support its efficacy and multiple rounds of data supporting its safety. Therefore, our team at Power estimates the safety of Emicizumab to be a 3."
Answered by AI
What is the precedent for using Emicizumab in medical treatments?
"Emicizumab was first investigated in 2018 at Xiangya Hospital of Centre-South University. So far, 7 studies have concluded and there are 9 more ongoing with several taking place in Detroit, Michigan."
Answered by AI
Does this type of experiment with humans happen often?
"Emicizumab, a medication used to treat haemophilia A, is being trialed in 9 different studies conducted across the world. The first of these clinical trials was completed in 2018 and sponsored by Hoffmann-La Roche. It involved 85 patients and successfully completed Phase 3 drug approval. In total, 7 Emicizumab studies have been concluded as of now."
Answered by AI
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