Actively Recruiting
Long-term Study Evaluating Joint Health in People With Haemophilia A Receiving Real-world Prophylactic Treatment With Efanesoctocog Alfa
Led by Swedish Orphan Biovitrum · Updated on 2026-03-24
250
Participants Needed
27
Research Sites
184 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
The rationale for this study is to further understand and describe the long-term prophylactic effectiveness of efanesoctocog alfa in preventing joint bleeds in a real-life setting.
CONDITIONS
Official Title
Long-term Study Evaluating Joint Health in People With Haemophilia A Receiving Real-world Prophylactic Treatment With Efanesoctocog Alfa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patient with a diagnosis of haemophilia A.
- Able to give signed informed consent and comply with study requirements.
- Prescribed efanesoctocog alfa prophylactic treatment within 6 months before or at enrolment.
- Received hemophilia prophylactic treatments for at least 12 months before starting efanesoctocog alfa.
- Have documented treatment and bleeding episode data from 12 months before efanesoctocog alfa treatment until enrolment.
- Willing to follow visit schedule and undergo study assessments including joint health scores and patient questionnaires.
- Able and willing to document all bleeding episodes and related treatments during the study.
- For the ultrasound subgroup, agree to annual joint ultrasound assessments.
You will not qualify if you...
- Have acquired haemophilia A or other blood clotting disorders besides hereditary haemophilia A.
- Have a positive FVIII inhibitor result (≥0.6 Bethesda unit/mL) from medical records between switching to efanesoctocog alfa and enrolment.
- Currently enrolled in another clinical interventional study or using an investigational drug within 3 months before enrolment.
- Judged by the investigator as unsuitable for participation, including inability or unwillingness to perform study assessments.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 27 locations
1
Sobi Investigational Site
Zagreb, Croatia
Actively Recruiting
2
Sobi Investigational Site
Brno, Czechia
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3
Sobi Investigational Site
Ostrava, Czechia
Actively Recruiting
4
Sobi Investigational Site
Prague, Czechia
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5
Sobi Investigational Site
Bordeaux, France
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6
Sobi Investigational Site
Marseille, France
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7
Sobi Investigational Site
Montpellier, France
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8
Sobi Investigational Site
Nantes, France
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9
Sobi Investigational Site
Paris, France
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10
Sobi Investigational Site
Rennes, France
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11
Sobi Investigational Site
Rouen, France
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12
Sobi Investigational Site
Berlin, Germany
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13
Sobi Investigational Site
Bonn, Germany
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14
Sobi Investigational Site
Frankfurt am Main, Germany
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15
Sobi Investigational Site
Hamburg, Germany
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16
Sobi Investigational Site
Munich, Germany
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17
Sobi Investigational Site
Dublin, Ireland
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18
Sobi Investigational Site
Turin, Italy
Actively Recruiting
19
Sobi Investigational Site
A Coruña, Spain
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20
Sobi Investigational Site
Barcelona, Spain
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21
Sobi Investigational Site
Málaga, Spain
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22
Sobi Investigational Site
Palma de Mallorca, Spain
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23
Sobi Investigational Site
Zaragoza, Spain
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24
Sobi Investigational Site
Birmingham, United Kingdom
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25
Sobi Investigational Site
Cardiff, United Kingdom
Actively Recruiting
26
Sobi Investigational Site
London, United Kingdom
Actively Recruiting
27
Sobi Investigational Site
Manchester, United Kingdom
Actively Recruiting
Research Team
S
Study Physician
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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