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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT03974113

Public ClinicalTrials.gov record NCT03974113. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 11, 2026, 4:54 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT03974113
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Genzyme, a Sanofi Company
Industry
Enrollment
32 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
1 Year to 11 Years
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 27, 2020
Primary completion
Aug 3, 2026
Completion
Aug 3, 2026
Last update posted
Sep 7, 2026

2020 – 2026

United States locations

U.S. sites
4
U.S. states
4
U.S. cities
4
Facility City State ZIP Site status
Children's Hospital Los Angeles Site Number : 8400002 Los Angeles California 90027
Hackensack University Medical Center- Site Number : 8400008 Hackensack New Jersey 07601
University Hospitals of Cleveland- Site Number : 8400007 Cleveland Ohio 44106
Penn State Milton S. Hershey Medical Center- Site Number : 8400006 Hershey Pennsylvania 17033

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03974113, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 7, 2026 · Synced Sep 11, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03974113 live on ClinicalTrials.gov.

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