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Emicizumab for Hemophilia A (HAVEN 7 Trial)
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.
HAVEN 7 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowHAVEN 7 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 48 Patients • NCT03020160HAVEN 7 Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Emicizumab
- 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.
- 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
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."
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."
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."
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."
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."
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."
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