NCT07895381Not yet recruiting
A Study to Describe Patient REal-world FitusiRan ExpeRience
Patient Experience With Fitusiran Prophylaxis in Adolescents and Adults With Hemophilia A or B With or Without Factor VIII or Factor IX Inhibitors in a Real-world Setting
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
This is a real-world, mixed-methods observational study conducted among adolescent (ages 12-17 years) and adult participants diagnosed with hemophilia A or B, with or without Factor VIII (FVIII) or Factor IX (FIX) inhibitors, who are treated with fitusiran. The study includes a prospective longitudinal cohort (Cohort 1) and a cross-sectional cohort (Cohort 2). Data collection includes patient-reported outcomes via online surveys, qualitative interviews conducted via teleconference, and electronic medical record (EMR) review to describe real-world patient experiences, treatment satisfaction, adherence, and clinical management of fitusiran.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 6 Oct 2026
- Start date
- 7 Oct 2026
- Primary completion date
- 2 Mar 2029
- Lead sponsor
- Sanofi
- Diseases
- Haemophilia
- NCT number
- NCT07895381
What you commit to
- Study type: Observational
- Planned participants: 100
- From 7 Oct 2026 to the primary completion date, 2 Mar 2029
- 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.
Other
- Prospective cohort: Participated in a clinical trial for fitusiran
- Cross-sectional cohort: Participated in the prospective cohort
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Who the study is looking for
- Participant is English speaking
- Participant is ≥ 12 years of age at the time of consent
- \-- Signed written informed consent by participants who are legally adults (i.e., have reached the age of majority as defined by local law) or legally authorized representative (e.g., parent) and assent (for participants under the age of majority by local law)
- Participant has a diagnosis of hemophilia A or B
- Participant is using fitusiran (QFITLIA) for:
- Prospective cohort: \< 6 months at the time of consent
- Cross-sectional cohort: 9-15 months at the time of consent
- Participant has access to an internet-connected computer or mobile device
- Participant is willing and able to participate in:
- Prospective cohort: Up to three 30-minute online surveys and two 60 minute virtual interviews over an approximately 12-month period
- Cross-sectional cohort: A 30-minute online survey and 60-minute virtual interview
- Participant resides in the US
Age in the registry: 12 years to - · Sex: All · 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 |
|---|---|---|---|
| Concentrics Center for Research Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.