{ "data": { "asOf": "2026-10-30T22:25:18.890Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT07895381", "title": "A Study to Describe Patient REal-world FitusiRan ExpeRience", "scientificTitle": "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", "status": "not_yet_recruiting", "studyType": "observational", "phase": [], "conditions": [ "Hemophilia A or B" ], "interventions": [], "sponsor": { "name": "Sanofi", "type": "INDUSTRY" }, "locations": [ { "city": "Indianapolis", "country": "United States", "facility": "Concentrics Center for Research" } ], "outcomes": { "other": [], "primary": [ "Patient-reported satisfaction with fitusiran measured by patient treatment preference questionnaire: Cohort 1 & 2", "Patient-reported satisfaction with previous treatment measured by bespoke qualitative patient survey and interview: Cohorts 1 & 2", "Patient-reported adherence to fitusiran measured by patient treatment preference questionnaire: Cohort 1", "Patient-reported reasons for switching to or starting and staying on fitusiran assessed through bespoke qualitative patient survey and interview: Cohort 1 & 2", "Patient-reported disadvantages of using fitusiran assessed by bespoke qualitative patient survey and interview: Cohort 1 & 2", "Patient-reported willingness to continue fitusiran assessed through patient treatment preference questionnaire: Cohort 1 & 2", "Change from baseline in patient-reported physical activity since starting fitusiran using PROBE questionnaire, EQ-5D-5L, EQ-5D-Y-3L: Cohort 1", "Change from baseline in patient-reported joint health since starting fitusiran using PROBE questionnaire, EQ-5D-5L, EQ-5D-Y-3L: Cohort 1", "Changes in patient reported outcomes, burdens and experiences (PROBE): Cohort 1", "Changes in EQ-5D-5L (for adult participants): Cohort 1 & 2", "Changes in EQ-5D-Y-3L (for adolescent participants): Cohort 1 & 2", "Patient-reported change in work or school attendance and productivity since starting fitusiran via the Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questionnaire adapted for hemophilia patients (WPAI+CIQ:HS): Cohort 1", "Changes in patient-reported hemophilia disease and treatment-related pain since starting fitusiran measured by PROMIS v2.0 - pain intensity 3a: Cohort 1", "Changes in patient-reported mental health status, such as stress and anxiety, since starting fitusiran, measured by the bespoke qualitative patient survey and interview: Cohorts 1 & 2", "Number of patient-reported antithrombin (AT) test and associated impacts measured by the bespoke qualitative patient survey and interview: Cohort 1 & 2", "Number of patient-reported liver function test (LFT) and associated impacts measured by the bespoke qualitative patient survey and interview: Cohort 1 & 2" ], "secondary": [ "Number of patients receiving different dose of fitusiran and rate of dosing regimen changes since starting fitusiran: Cohort 1 & 2", "Frequency of antithrombin (AT) and liver function test (LFT) performed: Cohort 1 & 2", "Frequency and type of treatment access barriers among patients initiating fitusiran: Cohort 1 & 2", "Patient-reported treatment satisfaction and compliance related to dose changes and longer dose adjustment period using patient treatment preference questionnaire and qualitative patient interview: Cohort 1 & 2" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n* Participant is English speaking\n* Participant is ≥ 12 years of age at the time of consent\n\n \\-- 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)\n* Participant has a diagnosis of hemophilia A or B\n* Participant is using fitusiran (QFITLIA) for:\n\n * Prospective cohort: \\< 6 months at the time of consent\n * Cross-sectional cohort: 9-15 months at the time of consent\n* Participant has access to an internet-connected computer or mobile device\n* Participant is willing and able to participate in:\n\n * Prospective cohort: Up to three 30-minute online surveys and two 60 minute virtual interviews over an approximately 12-month period\n * Cross-sectional cohort: A 30-minute online survey and 60-minute virtual interview\n* Participant resides in the US\n\nExclusion Criteria:\n\n* Prospective cohort: Participated in a clinical trial for fitusiran\n* Cross-sectional cohort: Participated in the prospective cohort\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.", "minimumAge": "12 Years", "healthyVolunteers": false }, "enrollment": { "type": "ESTIMATED", "count": 100 }, "startDate": "2026-10-07", "completionDate": "2029-03-02", "lastUpdated": "2026-10-26T00:00:00.000Z", "firstPosted": "2026-10-26T00:00:00.000Z", "resultsAvailable": false, "sourceRegistries": [ "clinicaltrials_gov" ], "sourceUrls": [ "https://clinicaltrials.gov/study/NCT07895381" ] }, "identifiers": [ { "idType": "nct", "idValue": "NCT07895381", "declaredBy": "clinicaltrials_gov" } ], "sourceRecords": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07895381", "sourceUrl": "https://clinicaltrials.gov/study/NCT07895381", "sourceStatus": "NOT_YET_RECRUITING", "retrievedAt": "2026-10-28T04:32:06.521Z", "payloadSha256": "da67115c41dca7677bfa66632ee0f41f4c2405cb50ea85d351be15541d99e88f", "piiRedacted": true } ], "citation": { "canonicalId": "NCT07895381", "sources": [ { "registry": "clinicaltrials_gov", "registryName": "ClinicalTrials.gov", "license": "public-domain", "sourceId": "NCT07895381", "verifyAt": "https://clinicaltrials.gov/study/NCT07895381", "retrievedAt": "2026-10-28T04:32:06.521Z", "payloadSha256": "da67115c41dca7677bfa66632ee0f41f4c2405cb50ea85d351be15541d99e88f", "text": "ClinicalTrials.gov, record NCT07895381 (https://clinicaltrials.gov/study/NCT07895381), retrieved 2026-10-28, licence: public-domain." } ], "crossRegistry": false, "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "text": "Trial NCT07895381, registered in ClinicalTrials.gov, retrieved 2026-10-28. 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