At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 60 enrolled
Drug / intervention
fitusiran +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating fitusiran and Bypassing agents for Hemophilia A and Hemophilia B. Completed, enrolled 60 participants across 58 sites in 17 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHemophilia A, Hemophilia B
CountriesAustralia, Canada, China, France, Germany, India, Italy, Japan, Malaysia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedJan 2018
Enrollment StartFeb 2018
Primary CompletionNov 2020
Study CompletionJun 2021
TodayJul 2026
First PostedJan 31, 2018
Enrollment StartFeb 14, 2018
Primary CompletionNov 25, 2020
Study CompletionJun 23, 2021
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 8.4 years ago
Interventions
fitusirandrug
solution for injection; by subcutaneous (SC) injection
Bypassing agentsdrug
solution for injection; by intravenous (IV) injection