NCT03417102

A Study of Fitusiran (ALN-AT3SC) in Severe Hemophilia A and B Patients With Inhibitors

ATLAS-INH: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, With Inhibitory Antibodies to Factor VIII or IX

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: Male
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to determine the frequency of bleeding episodes in participants receiving fitusiran as prophylactic treatment of hemophilia compared to participants who were assigned to continue with their regular medication. In addition, the study assessed safety, quality of life, pharmacodynamics (PD), and pharmacokinetics (PK).

Detailed description

The duration of treatment with fitusiran was 9 months. The estimated total time on study, inclusive of screening, for each participant was up to 11 months for all participants who enroll in the extension study and participants in the on-demand arm who did not enroll in the extension study. The estimated total time on study was up to 17 months in fitusiran treatment arm participants who did not enroll in the extension study due to the requirement for up to an additional 6 months of follow-up monitoring for antithrombin levels.

Conditions

• Hemophilia A
• Hemophilia B

Interventions

Type	Name	Description
DRUG	fitusiran	solution for injection; by subcutaneous (SC) injection
DRUG	Bypassing agents	solution for injection; by intravenous (IV) injection

Timeline

• Start date: 2018-02-14
• Primary completion: 2020-11-25
• Completion: 2021-06-23
• First posted: 2018-01-31
• Last updated: 2022-03-28
• Results posted: 2021-12-21

Locations

58 sites across 17 countries: United States, Australia, Canada, China, France, Germany, India, Italy, Japan, Malaysia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study