Condition: Haemophilia A (Moderate or Severe) · Sponsor: Swedish Orphan Biovitrum
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.
This description comes directly from the study's public registry record.
Study Physician · +46 (0)8 697 20 00 · medical.info@sobi.com
Clinical Program Lead · +46 (0)8 697 20 00 · medical.info@sobi.com
Always discuss trial participation with your own doctor first.
| Sobi Investigational Site | Plovdiv, Bulgaria | Active Not Recruiting |
| Sobi Investigational Site | Sofia, Bulgaria | Active Not Recruiting |
| Sobi Investigational Site | Brest, France | Active Not Recruiting |
| Sobi Investigational Site | Bron, France | Active Not Recruiting |
| Sobi Investigational Site | Lille, France | Active Not Recruiting |
| Sobi Investigational Site | Strasbourg, France | Withdrawn |
| Sobi Investigational Site | Athens, Greece | Active Not Recruiting |
| Sobi Investigational Site | Catanzaro, Italy | Active Not Recruiting |
| Sobi Investigational Site | Florence, Italy | Active Not Recruiting |
| Sobi Investigational Site | Milan, Italy | Active Not Recruiting |
| Sobi Investigational Site | Naples, Italy | Recruiting |
| Sobi Investigational Site | Parma, Italy | Active Not Recruiting |
+ 9 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT06716814