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ATLAS-OLE: An Open-label, Long-term Safety and Efficacy Study of Fitusiran in Patients with Hemophilia A or B, with or without Inhibitory Antibodies to Factor VIII or IX

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508884-59-00
Acronym
LTE15174
Enrollment
18
Registered
2024-05-17
Start date
2024-06-03
Completion date
2025-11-17
Last updated
2025-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophilia A or Hemophilia B

Brief summary

​​Number of participants with treatment emergent adverse events (TEAEs)​

Detailed description

Annualized bleeding rate in the treatment period., Annualized spontaneous bleeding rate in the treatment period., Annualized joint bleeding rate in the treatment period., Change in haemophilia quality of life questionnaire for adults (HaemAQoL) physical health score in the treatment period (in participants ≥17 years of age).

Interventions

DRUGCOAGULATION FACTOR VIII
DRUGCOAGULATION FACTOR VIIA
DRUGCOAGULATION FACTOR IX
DRUGSAR439774
DRUGFACTOR VIII INHIBITOR BYPASSING ACTIVITY
DRUGANTITHROMBIN III

Sponsors

Genzyme Corp.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
Male
Age
0 Years to No maximum

Design outcomes

Secondary

MeasureTime frame
Annualized bleeding rate in the treatment period., Annualized spontaneous bleeding rate in the treatment period., Annualized joint bleeding rate in the treatment period., Change in haemophilia quality of life questionnaire for adults (HaemAQoL) physical health score in the treatment period (in participants ≥17 years of age).—

Primary

MeasureTime frame
​​Number of participants with treatment emergent adverse events (TEAEs)​—

Countries

Denmark, France, Hungary, Ireland, Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026