NCT07582276Recruiting
A Prospective Assessment of Bone Health in Patients With Severe Hemophilia A on Factor VIII vs Factor Mimetic Prophylaxis (Efa Emi Bone Health Study)
A Multi-institution Prospective Assessment of Bone Health in Patients With Severe Hemophilia A on Factor VIII vs Factor Mimetic Prophylaxis (Efa Emi Bone Health Study)
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
This study will compare bone mineral density in patients with severe hemophilia A receiving prophylaxis with emicizumab or efanesoctocog alfa. Participants will undergo assessments of bone mineral density, bone remodeling biomarkers, thrombin generation, plasmin generation, and joint health over a five-year period. The study aims to evaluate whether differences in prophylactic therapy are associated with differences in bone health outcomes.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 6 May 2026
- Start date
- 21 Sept 2026
- Primary completion date
- Sept 2031
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Diseases
- Haemophilia
- NCT number
- NCT07582276
What you commit to
- Study type: Observational
- Planned participants: 50
- From 21 Sept 2026 to the primary completion date, Sept 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active Factor VIII inhibitors at the time of enrollment
- History of bone fractures or surgical repair within 8 weeks prior to enrollment.
Other illness
- Diagnosis of a bleeding disorder other than or in addition to severe hemophilia A.
- History of a disease known to influence bone metabolism unrelated to a bleeding disorder. (Examples: Paget's disease, osteogenesis imperfecta, Ehlers Danlos syndrome, Hyperparathyroidism)
- Documented HIV infection or HCV infection (whether in progress or cured) at the cirrhotic stage.
Lab values
- Past or present treatment with any anti-osteoporotic medication, excluding oral vitamin D or oral calcium supplements.
Other
- Unwillingness of the participant, parent, or legally authorized representative to provide informed consent.
- Presence of a non-removable metal device that would interfere with research procedures.
- Inability to tolerate a DEXA scan due to limited range of motion or body habitus.
- Participants with weight \>300 pounds, due to limitations of DEXA scanner
Who the study is looking for
- The participant or legally authorized representative is willing and able to provide written informed consent.
- Diagnosis of severe hemophilia A (factor VIII activity \< 1%).
- Male sex.
- Age between 30 and 50 years (inclusive).
- BMI between 18.5 and 40 kg/m2
- The participant must have been on prophylaxis with Efanesoctocog alfa or Emicizumab for at least 3 months prior to enrollment and intend to remain on the current regimen for the next 5 years.
- Willingness to undergo all research procedures, including DEXA scans and the collection of blood samples.
- Willingness to complete all standard-of-care bleeding and treatment logs.
Age in the registry: 30 years to 50 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Arkansas Children's Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.