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RNAi Therapeutics

Fitusiran for Hemophilia (ATLAS-NEO Trial)

Phase 3

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 (d1) to day 505, and from d1 to day 1009, and during soc from day-168 to d-1

Awards & highlights

ATLAS-NEO Trial Summary

This trial is for hemophilia A or B sufferers to measure how well fitusiran treats bleeding episodes compared to the current standard of care. Participants will have phone & site visits every 2-8 weeks for 50 months. Home/remote visits may be allowed.

Who is the study for?

This trial is for male teens and adults with severe Hemophilia A or B, who've had at least 4 bleeding episodes in the last 6 months. They must be willing to follow study rules and give consent. Those with liver disease, thrombophilic disorders, certain viral infections, low CD4 counts if HIV positive, poor kidney function, other bleeding disorders besides hemophilia or a history of blood clots can't join.Check my eligibility

What is being tested?

The trial tests Fitusiran injections under the skin against standard treatments (clotting factors or bypassing agents) for preventing bleeds in Hemophilia patients. It's an open-label study where participants switch from their current treatment to Fitusiran for about three years after a six-month observation period on their usual care.See study design

What are the potential side effects?

Fitusiran may cause injection site reactions and has potential risks like developing blood clots due to its effect on clotting proteins. Standard treatments' side effects vary but include allergic reactions and complications related to long-term use.

ATLAS-NEO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (d1) to day 505, and from d1 to day 1009, and during soc from day-168 to d-1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 (d1) to day 505, and from d1 to day 1009, and during soc from day-168 to d-1

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (d1) to day 505, and from d1 to day 1009, and during soc from day-168 to d-1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Annualized bleeding rate (ABR) in the fitusiran primary efficacy period

Secondary outcome measures

Annualized bleeding rate (ABR) in the fitusiran 18-month efficacy period

Annualized bleeding rate (ABR) in the fitusiran 36-month treatment period

Annualized bleeding rate (ABR) while on fitusiran prophylaxis in the fitusiran primary efficacy period and ABR while on on-demand standard of care (SOC) in the SOC period

+6 more

ATLAS-NEO Trial Design

1Treatment groups

Experimental Treatment

Group I: All participantsExperimental Treatment3 Interventions

In standard of care (SOC) period, participants will receive on-demand or prophylactic treatment with clotting factor concentrates (CFCs) or bypassing agents (BPAs) for 6 months (from Day -168 to Day -1). In fitusiran treatment period, participants will receive subcutaneous fitusiran prophylaxis once every other month (Q2M) or once monthly (QM) for 36 months (from Day 1 to Day 1009). In case of bleeding events participants will receive IV CFCs or BPAs. Participants may receive Antithrombin concentrate (ATIIIC) as rescue medicine. .

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fitusiran

2018

Completed Phase 3

~80

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,905 Total Patients Enrolled

2 Trials studying Hemophilia

3,035 Patients Enrolled for Hemophilia

Clinical Sciences & OperationsStudy DirectorSanofi

862 Previous Clinical Trials

2,019,763 Total Patients Enrolled

3 Trials studying Hemophilia

393 Patients Enrolled for Hemophilia

Media Library

Fitusiran (RNAi Therapeutics) Clinical Trial Eligibility Overview. Trial Name: NCT05662319 — Phase 3

Hemophilia Research Study Groups: All participants

Hemophilia Clinical Trial 2023: Fitusiran Highlights & Side Effects. Trial Name: NCT05662319 — Phase 3

Fitusiran (RNAi Therapeutics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05662319 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are all individuals enrolled in this trial acceptable by the FDA?

"Our team of evaluators at Power assigned the safety rating for all patients a 3, based on sound evidence from Phase 3 trials that support both efficacy and security."

Answered by AI

How many volunteers have been recruited for this clinical trial?

"Yes, clinicaltrials.gov confirms that the trial is currently recruiting participants who were first posted on January 13th 2023 and was last updated on 1/12/2023. 75 volunteers are needed from one medical centre."

Answered by AI

Are any fresh participants being sought for this experiment?

"Affirmative. According to the clinicaltrials.gov details, this medical study is currently enrolling candidates with its inception date being January 13th 2023 and last update on 12/1/2023. A total of 75 patients are sought from 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia

2023. "A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05662319.

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