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

NCT06716814 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2026-04-20

No results posted yet for this study

Summary

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.

Conditions

  • Haemophilia A (Moderate or Severe)

Interventions

DRUG

Efanesoctocog alfa

Treatment starts when the patient completes the parent study and continues until efanesoctocog alfa is commercially available in each patient's respective country, or until March 2027, whichever comes first.

Sponsors & Collaborators

  • PSI CRO

    collaborator INDUSTRY

  • Swedish Orphan Biovitrum

    lead INDUSTRY

Principal Investigators

  • Medical Development Lead · Sobi AB

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-06
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • Bulgaria
  • France
  • Greece
  • Italy
  • Norway
  • Spain
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06716814 on ClinicalTrials.gov