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Fitusiran Prophylaxis in Male Pediatric Subjects Aged 1 to Less Than 12 Years With Hemophilia A or B — ATLAS-PEDS  

Hemophilia Clinical Trial

Official title:
ATLAS-PEDS: An Open-label, Multinational Study of Fitusiran Prophylaxis in Male Pediatric Subjects Aged 1 to Less Than 12 Years With Hemophilia A or B

Clinical Trial Summary

Primary Objective: - To confirm appropriate dose levels of fitusiran when administered to male pediatric participants (ages 1 to <12 years of age) with severe hemophilia A or B Secondary Objectives: - To characterize the safety and tolerability - To determine fitusiran plasma concentrations at selected time points

Clinical Trial Description

The estimated total time on study is up to 256 weeks for participants who roll over into the extension study and up to 280 weeks for participants who do not roll over into the extension study (due to the requirement for up to an additional 6 months of follow-up for monitoring of AT levels). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03974113
Study type Interventional
Source Sanofi
Contact
Status Active, not recruiting
Phase Phase 3
Start date January 28, 2020
Completion date August 1, 2028
View Details
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