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Fitusiran for Hemophilia (ATLAS-OLE Trial)
ATLAS-OLE Trial Summary
This trial will study the safety and effectiveness of an experimental drug called fitusiran in people with a bleeding disorder.
ATLAS-OLE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowATLAS-OLE 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 • 80 Patients • NCT03549871ATLAS-OLE Trial Design
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Who is running the clinical trial?
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- I am 12 years old or older.I use treatments other than factor concentrates or BPAs for my hemophilia.I have a serious liver condition.I had surgery within the last 14 days or am receiving treatment for bleeding after surgery.I have had a blood clot in an artery or vein.I use medication regularly to prevent bleeding, except during study breaks.You have severe hemophilia A or B and have already participated in a Phase 3 clinical trial for fitusiran.I can sign the consent form and follow the study rules.I am male.My liver enzymes are within the required range for the study.
- Group 1: Fitusiran
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What are the short- and long-term risks associated with Fitusiran?
"Based on our research, we believe that the safety of Fitusiran can be classified as a 3. This is due to the fact that this is a Phase 3 trial, and thus there is some evidence of efficacy as well as multiple rounds of data supporting safety."
Are there any other notable scientific studies that have used Fitusiran?
"Fitusiran was first researched in 2015. So far, 4 studies have completed while 3 more are still ongoing. The current active recruitment trials for Fitusiran are based out of Ann Arbor, Massachusetts."
Are there any unfilled spots in this clinical trial that patients could take advantage of?
"According to clinicaltrials.gov, this study is no longer active. It was first posted on 1/9/2019, and the last update was on 6/8/2022. Although this study is no longer looking for participants, there are 94 other trials that are still recruiting."
How many people are currently being helped by this trial?
"This particular clinical trial is not recruiting new patients at this time; however, there are other 91 trials for hemophilia A and 3 trials for Fitusiran that are."
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