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RNAi Therapeutic
Fitusiran for Hemophilia (ATLAS-OLE Trial)
Phase 3
Waitlist Available
Research Sponsored by Genzyme, a Sanofi Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant must be at least 12 years of age inclusive, at the time of signing the informed consent
Male
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from study baseline (day 1) up to maximum 88 months
Awards & highlights
ATLAS-OLE Trial Summary
This trial will study the safety and effectiveness of an experimental drug called fitusiran in people with a bleeding disorder.
Who is the study for?
This trial is for males aged 12 or older with severe hemophilia A or B who have finished a Phase 3 fitusiran study. They must be able to consent and follow the study rules. It's not for those on certain other treatments, with liver issues, history of blood clots, recent surgery, or in gene therapy trials.Check my eligibility
What is being tested?
The trial tests the long-term safety and effectiveness of Fitusiran in managing bleeding episodes in hemophilia patients. It looks at how often bleeding occurs and its impact on quality of life over time.See study design
What are the potential side effects?
While specific side effects are not listed here, the trial aims to monitor the long-term safety and tolerability of Fitusiran which may include tracking any adverse reactions related to bleeding management.
ATLAS-OLE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 12 years old or older.
Select...
I am male.
ATLAS-OLE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from study baseline (day 1) up to maximum 88 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from study baseline (day 1) up to maximum 88 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with treatment emergent adverse events (TEAEs)
Secondary outcome measures
Annualized bleeding rate (ABR)
Annualized joint bleeding rate
Annualized spontaneous bleeding rate
+1 moreSide effects data
From 2022 Phase 3 trial • 80 Patients • NCT0354987119%
Upper Respiratory Tract Infection
14%
Alanine Aminotransferase Increased
14%
Fibrin D Dimer Increased
10%
Cough
10%
Cholelithiasis
10%
Hepatic Steatosis
10%
Injection Site Pain
10%
Injection Site Erythema
10%
Abdominal Pain
10%
Cholecystitis
5%
Toothache
5%
Vomiting
5%
Arthropod Bite
5%
Synovitis
5%
Nasopharyngitis
5%
Haemophilic Arthropathy
5%
Central Venous Catheter Removal
5%
Aspartate Aminotransferase Increased
5%
Headache
5%
Influenza
5%
Pancreatitis Acute
5%
Arthralgia
5%
Fall
5%
Femur Fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort A: SAS 1 - Fitusiran 80 mg QM
Overall: SAS 1 - Fitusiran 80 mg QM
Overall: SAS 1 - Factor/BPA Prophylaxis
Cohort A: SAS 2 - Fitusiran 50 mg Q2M
Cohort A: SAS 1 - BPA Prophylaxis
Cohort B: SAS 1 - Factor Prophylaxis
Cohort B: SAS 1 - Fitusiran 80 mg QM
Cohort A: SAS 2 - BPA Prophylaxis
ATLAS-OLE Trial Design
1Treatment groups
Experimental Treatment
Group I: FitusiranExperimental Treatment1 Intervention
Participants will be administered fitusiran as a subcutaneous injection once monthly or every other month for up to 48 months post initiation of modified IMP dose/frequency or until fitusiran becomes commercially available, whichever comes first.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fitusiran
2018
Completed Phase 3
~80
Find a Location
Who is running the clinical trial?
Genzyme, a Sanofi CompanyLead Sponsor
524 Previous Clinical Trials
85,349 Total Patients Enrolled
2 Trials studying Hemophilia
112 Patients Enrolled for Hemophilia
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,019,018 Total Patients Enrolled
3 Trials studying Hemophilia
187 Patients Enrolled for Hemophilia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Fitusiran
Awards:
This trial has 2 awards, including:- 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.
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.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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