Study to Provide Continued Access to Treatment for Patients Completing a Previous Trial With Efanesoctocog Alfa

Study acronym: LIBERTY
StatusActive, Not Recruiting
PhasePhase 3
Started

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Record History

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  1. Enrollment closed, study ongoing
    • Final enrollment: 89 participants (planned 104)
    • Study sites: 21 to 20
    • Eligibility criteria expanded, about 6 words
  2. Trial sites reduced: 24 → 21 locationsv8
  3. Study sites: 22 to 24
    • Eligibility criteria revised
    v7
  4. Site details revised at 1 of 22 sitesv6
  5. Site details revised at 20 of 22 sitesv5
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  1. Primary and study completion dates: Aug 2026 to Mar 2027
    • Enrollment target: 78 to 104
    • Study sites: 20 to 22
    v4
  2. Study sites: 5 to 20v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2025 to Mar 6, 2025
    • Site details revised at 5 of 5 sites
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a multinational, prospective, open-label, roll-over study in patients with haemophilia A, ≥6 years of age, who have completed participation in any of the parental studies with efanesoctocog alfa; XTEND-ed study (LTS16294), FREEDOM study (Sobi.BIVV001-001), PK comparison study (Sobi.BIVV001-003) or SHINE study (Sobi.BIVV001-004). The aim of the study is to provide patients with continuous benefit from efanesoctocog alfa treatment and to further continue clinical monitoring for safety and efficacy until efanesoctocog alfa is commercially available in each patient's respective country (or until March 2027, whichever comes first). The study starts with the Baseline Visit, which will be done in connection to the end of treatment at the EoT/EoS visit (or equivalent) in the respective parent study. Subsequent study visits (on site or phone call) will be done approximately every 13 weeks until End of Treatment. An End of Study safety phone call will be done 14 (+7) days after the End of Treatment Visit.
Trial Details
NCT Number NCT06716814
Lead Sponsor Swedish Orphan Biovitrum
Collaborators: PSI CRO
Conditions
(from sponsor)		 Haemophilia A (Moderate or Severe)
Related terms Blood Coagulation Disorders, Coagulation Protein Disorders, Hemophilia A, Lymphoma, Follicular
Enrollment 89 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov