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New treatment option for Haemophilia A (Moderate or Severe)
Official title Study to Provide Continued Access to Treatment for Patients Completing a Previous Trial With Efanesoctocog Alfa
ClinicalTrials.gov ID: NCT06716814
What this study is testing
What is Efanesoctocog alfa?
Efanesoctocog alfa is an investigational medicine, being studied as a potential treatment for haemophilia a (moderate or severe).
Also referred to as BIVV001, Altuvoct.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 and older, men only
You may be able to join if
- Capable of giving signed informed consent. Parents or legally designated representatives' consent is required for patients who are below 18 years of...
- Must have completed one of the required parent studies: Sobi.BIVV001-001, Sobi.BIVV001-003, LTS16294, or Sobi.BIVV001-004, and be receiving a...
- Willingness and ability of patient or their parent or legally designated representative to complete training in the use of the study patient diary...
You likely can't join if
- Positive inhibitor result, defined as ≥0.6 Bethesda units (BU)/mL, present at the Baseline Visit.
- Ongoing or planned participation in any treatment clinical study at the Baseline Visit.
- Patient not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or patients...
The study team makes the final eligibility decision.
Where it's taking place
- Plovdiv, Bulgaria
- Sofia, Bulgaria
- Brest, France
- Bron, France
- Lille, France
- Strasbourg, France
- Athens, Greece
- Catanzaro, Italy
- Florence, Italy
- Milan, Italy
- Naples, Italy
- Parma, Italy
- Rome, Italy
- Rozzano, Italy
- Vicenza, Italy
- Oslo, Norway
- A Coruña, Spain
- Zaragoza, Spain
- Gothenburg, Sweden
- Lund, Sweden
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 6 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Plovdiv, Bulgaria; Sofia, Bulgaria; Brest, France; Bron, France; Lille, France; Strasbourg, France and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.