Trial · NCT07895381
A Study to Describe Patient REal-world FitusiRan ExpeRience
NCT07895381, Not yet recruiting, Sanofi
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Describe Patient REal-world FitusiRan ExpeRience. Trials, record NCT07895381. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07895381
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Describe Patient REal-world FitusiRan ExpeRience
- NCT number
- NCT07895381
- Status
- Not yet recruiting
- Enrollment
- 100 participants, estimated
- Lead sponsor
- Sanofi
- Conditions
- Hemophilia A or B
- First posted
- 2026-10-26
- Last updated
- 2026-10-26
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patient-reported satisfaction with fitusiran measured by patient treatment preference questionnaire: Cohort 1 & 2 | Over 12 months of treatment with fitusiran | The Patient Treatment Preference Questionnaire is a five-item instrument designed to evaluate treatment preferences. Items assess satisfaction with treatment, preferred treatment options, and willingness to continue treatment. |
| Primary | Patient-reported satisfaction with previous treatment measured by bespoke qualitative patient survey and interview: Cohorts 1 & 2 | Over 12 months of treatment with fitusiran | The Bespoke survey covering patient satisfaction and transition to, or changes made while taking Fitusiran. |
| Primary | Patient-reported adherence to fitusiran measured by patient treatment preference questionnaire: Cohort 1 | Over 12 months of treatment with fitusiran | The Patient Treatment Preference Questionnaire is a five-item instrument designed to evaluate treatment preferences. Items assess satisfaction with treatment, preferred treatment options, and willingness to continue treatment. |
| Primary | Patient-reported reasons for switching to or starting and staying on fitusiran assessed through bespoke qualitative patient survey and interview: Cohort 1 & 2 | Over 12 months of treatment with fitusiran | The Bespoke survey covering patient satisfaction and transition to, or changes made while taking Fitusiran. |
| Primary | Patient-reported disadvantages of using fitusiran assessed by bespoke qualitative patient survey and interview: Cohort 1 & 2 | Over 12 months of treatment with fitusiran | The Bespoke survey covering patient satisfaction and transition to, or changes made while taking Fitusiran. |
| Primary | Patient-reported willingness to continue fitusiran assessed through patient treatment preference questionnaire: Cohort 1 & 2 | Over 12 months of treatment with fitusiran | The Patient Treatment Preference Questionnaire is a five-item instrument designed to evaluate treatment preferences. Items assess satisfaction with treatment, preferred treatment options, and willingness to continue treatment. |
| Primary | Change from baseline in patient-reported physical activity since starting fitusiran using PROBE questionnaire, EQ-5D-5L, EQ-5D-Y-3L: Cohort 1 | Over 12 months of treatment with fitusiran | The Patient-Reported Outcomes Burdens and Experiences (PROBE) questionnaire is designed to assess the health status, treatment experiences, and QoL of individuals with hemophilia. Total PROBE score ranges from 0 to 1; a lower score means higher burden. The EQ-5D-5L is an adult measure of general health-related quality of life and health status, composed of five items and a visual analogue scale (VAS). VAS score ranges from 0 (worst imaginable health) to 100 (best imaginable health). The EQ-5D-Y-3L assesses the same health domains as the EQ-5D-5L but uses simplified, child-friendly language. VAS score ranges from 0 (worst imaginable health) to 100 (best imaginable health). |
| Primary | Change from baseline in patient-reported joint health since starting fitusiran using PROBE questionnaire, EQ-5D-5L, EQ-5D-Y-3L: Cohort 1 | Over 12 months of treatment with fitusiran | The Patient-Reported Outcomes Burdens and Experiences (PROBE) questionnaire is designed to assess the health status, treatment experiences, and QoL of individuals with hemophilia. Total PROBE score ranges from 0 to 1; a lower score means higher burden. The EQ-5D-5L is an adult measure of general health-related quality of life and health status, composed of five items and a visual analogue scale (VAS). VAS score ranges from 0 (worst imaginable health) to 100 (best imaginable health). The EQ-5D-Y-3L assesses the same health domains as the EQ-5D-5L but uses simplified, child-friendly language. VAS score ranges from 0 (worst imaginable health) to 100 (best imaginable health). |
| Primary | Changes in patient reported outcomes, burdens and experiences (PROBE): Cohort 1 | Over 12 months of treatment with fitusiran | The Patient-Reported Outcomes Burdens and Experiences (PROBE) questionnaire assesses health status, treatment experiences, and quality of life of individuals with hemophilia. Total PROBE score ranges from 0 to 1; a lower score means higher burden. |
| Primary | Changes in EQ-5D-5L (for adult participants): Cohort 1 & 2 | Over 12 months of treatment with fitusiran | The EQ-5D-5L is an adult measure of general health-related quality of life and health status, composed of five items and a visual analogue scale (VAS). VAS score ranges from 0 (worst imaginable health) to 100 (best imaginable health). |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07895381
GET https://conductscience.org/api/trials/v1/NCT07895381/registered