Actively Recruiting
Study to Provide Continued Access to Treatment for Patients Completing a Previous Trial With Efanesoctocog Alfa
Led by Swedish Orphan Biovitrum · Updated on 2026-04-20
104
Participants Needed
24
Research Sites
103 weeks
Total Duration
On this page
Sponsors
S
Swedish Orphan Biovitrum
Lead Sponsor
P
PSI CRO
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Study to Provide Continued Access to Treatment for Patients Completing a Previous Trial With Efanesoctocog Alfa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide signed informed consent, or if under 18, have consent from a parent or legal representative and assent if appropriate
- Completed one of the required parent studies (Sobi.BIVV001-001, Sobi.BIVV001-003, LTS16294, or Sobi.BIVV001-004)
- Currently receiving clinical benefit from efanesoctocog alfa treatment as judged by the Investigator
- Willing and able to complete training on using the study diary and to use the diary throughout the study
You will not qualify if you...
- Positive inhibitor result of 0.6 Bethesda units/mL or higher at Baseline Visit
- Participating in any other interventional clinical study at Baseline Visit
- Deemed unsuitable for participation by the Investigator due to medical, clinical conditions, or risk of noncompliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
Sobi Investigational Site
Plovdiv, Bulgaria
Actively Recruiting
2
Sobi Investigational Site
Sofia, Bulgaria
Actively Recruiting
3
Sobi Investigational Site
Bordeaux, France
Withdrawn
4
Sobi Investigational Site
Brest, France
Active, Not Recruiting
5
Sobi Investigational Site
Bron, France
Active, Not Recruiting
6
Sobi Investigational Site
Le Kremlin-Bicêtre, France
Withdrawn
7
Sobi Investigational Site
Lille, France
Active, Not Recruiting
8
Sobi Investigational Site
Marseille, France
Withdrawn
9
Sobi Investigational Site
Strasbourg, France
Withdrawn
10
Sobi Investigational Site
Athens, Greece
Actively Recruiting
11
Sobi Investigational Site
Catanzaro, Italy
Actively Recruiting
12
Sobi Investigational Site
Florence, Italy
Actively Recruiting
13
Sobi Investigational Site
Milan, Italy
Actively Recruiting
14
Sobi Investigational Site
Naples, Italy
Actively Recruiting
15
Sobi Investigational Site
Parma, Italy
Actively Recruiting
16
Sobi Investigational Site
Rome, Italy
Actively Recruiting
17
Sobi Investigational Site
Rozzano, Italy
Actively Recruiting
18
Sobi Investigational Site
Vicenza, Italy
Actively Recruiting
19
Sobi Investigational Site
Oslo, Norway
Actively Recruiting
20
Sobi Investigational Site
A Coruña, Spain
Active, Not Recruiting
21
Sobi Investigational Site
Zaragoza, Spain
Active, Not Recruiting
22
Sobi Investigational Site
Gothenburg, Sweden
Actively Recruiting
23
Sobi Investigational Site
Lund, Sweden
Actively Recruiting
24
Sobi Investigational Site
Stockholm, Sweden
Actively Recruiting
Research Team
S
Study Physician
CONTACT
C
Clinical Program Lead
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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