A multinational, prospective, open-label, roll-over study (LIBERTY) to provide post-trial access to treatment for patients with severe haemophilia A who have completed a previous trial with efanesoctocog alfa

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506537-29-00

Acronym

Sobi.BIVV001-002

Enrollment

109

Registered

2024-04-11

Start date

2025-02-24

Completion date

Unknown

Last updated

2025-09-18

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

Conditions

Haemophilia A

Brief summary

Safety Endpoint: The occurrence of adverse events (AEs), including serious adverse events (SAEs) and AESIs, Efficacy Endpoints: To collect further data on the efficacy of efanesoctocog alfa as a prophylaxis treatment; To collect further data on the efficacy of efanesoctocog alfa in the treatment of bleeding episodes

Interventions

DRUGBIVV001 - efanesoctocog alfa

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Safety Endpoint: The occurrence of adverse events (AEs), including serious adverse events (SAEs) and AESIs, Efficacy Endpoints: To collect further data on the efficacy of efanesoctocog alfa as a prophylaxis treatment; To collect further data on the efficacy of efanesoctocog alfa in the treatment of bleeding episodes	—

Countries

Bulgaria, France, Germany, Greece, Italy, Netherlands, Norway, Slovenia, Spain, Sweden

Outcome results

None listed

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