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New treatment option for Hemophilia A
Official title Long-term Study Evaluating Joint Health in People With Haemophilia A Receiving Real-world Prophylactic Treatment With Efanesoctocog Alfa
ClinicalTrials.gov ID: NCT06940830
What this study is testing
What is Efanesoctocog alfa?
Efanesoctocog alfa is an investigational medicine, being studied as a potential treatment for hemophilia a.
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
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Male or female patient with a diagnosis of haemophilia A.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)...
- Prescribed with efanesoctocog alfa prophylactic treatment within 6 months prior to study enrolment or at the latest at the enrolment visit, in...
- Must have received prophylactic treatment(s) with any haemophilia product(s) for at least 12 months prior to being prescribed with efanesoctocog alfa...
- Have documented pre-study treatment data on haemophilia prophylaxis prescriptions and on treated bleeding episodes from the 12-months prior to being...
You likely can't join if
- Acquired haemophilia A and other blood clotting disorders than hereditary haemophilia A.
- Any positive FVIII inhibitor result (defined as inhibitor titre ≥0.6 Bethesda unit [BU]/mL) from the medical records in connection to the switch to...
- Enrolment in a concurrent clinical treatment study, or intake of an investigational medicinal product (IMP), including for haemophilia prophylaxis...
- Patient not suitable for participation, whatever the reason, as judged by the Investigator, e.g., patient is not able or willing to perform the study...
See the full eligibility criteria
- Male or female patient with a diagnosis of haemophilia A.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Prescribed with efanesoctocog alfa prophylactic treatment within 6 months prior to study enrolment or at the latest at the enrolment visit, in accordance with local regulations.
- Must have received prophylactic treatment(s) with any haemophilia product(s) for at least 12 months prior to being prescribed with efanesoctocog alfa treatment.
- Have documented pre-study treatment data on haemophilia prophylaxis prescriptions and on treated bleeding episodes from the 12-months prior to being prescribed efanesoctocog alfa treatment and until enrolment into this...
- Willing to adhere to the visit schedule and to undergo mandatory study assessment (HJHS, PROs).
- Willingness and the ability of the patient or their legally designated representative to document all bleeding episodes, including any treatments for those episodes.
- For HEAD-US subgroup: Accept to undergo annual ultrasound assessment on the index joints (ankles, elbows, knees).
- Acquired haemophilia A and other blood clotting disorders than hereditary haemophilia A.
- Any positive FVIII inhibitor result (defined as inhibitor titre ≥0.6 Bethesda unit [BU]/mL) from the medical records in connection to the switch to efanesoctocog alfa until the enrolment visit.
- Enrolment in a concurrent clinical treatment study, or intake of an investigational medicinal product (IMP), including for haemophilia prophylaxis, within 3 months prior to enrolment in this study.
- Patient not suitable for participation, whatever the reason, as judged by the Investigator, e.g., patient is not able or willing to perform the study assessments.
The study team makes the final eligibility decision.
Where it's taking place
- Zagreb, Croatia
- Brno, Czechia
- Ostrava, Czechia
- Prague, Czechia
- Bordeaux, France
- Marseille, France
- Montpellier, France
- Nantes, France
- Paris, France
- Rennes, France
- Rouen, France
- Berlin, Germany
- Bonn, Germany
- Frankfurt am Main, Germany
- Hamburg, Germany
- Munich, Germany
- Dublin, Ireland
- Catania, Italy
- Padua, Italy
- Turin, Italy
+ 9 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 all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zagreb, Croatia; Brno, Czechia; Ostrava, Czechia; Prague, Czechia; Bordeaux, France; Marseille, France and 23 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.