Hemophilia AACTIVIIITYNCT06530030
Goal Attainment and Physical Activity in People With Hemophilia A
An observational study of Hemophilia A, run by Sanofi at 1 site in United States.
Trial summary
This is a Phase 4, multi-center, observational study conducted in patients aged 12 to 50 years with moderate or severe hemophilia A who are newly starting prophylaxis with efa in the US and Japan. This study aims to enroll 35 patients. Read more about this study
- Who is it for?
- Ages 12 to 50 years
- Conditions the study is for
- Hemophilia A
- What is being tested?
- efanesoctocog alfa
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2024to 18 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with moderate or severe Hemophilia A
Who may be able to join
- At enrollment, newly starting prophylaxis therapy with efanesoctocog alfa according to usual clinical practice, with efanesoctocog alfa initiated within 6 months after the enrollment visit
- Diagnosis of moderate (endogenous FVIII activity between 1% to 5% of normal) or severe (endogenous FVIII activity <1% of normal) hemophilia A
- Aged 12 to 50 years at time of enrollment, inclusive
- Access to a smartphone device (Android version 12.0 or higher; or iOS 13 or higher) with Bluetooth 4.0 (minimum) or 5.0 (recommended) capabilities for compatibility with physical activity tracker
- Availability of home-based access to internet for electronic patient-reported outcome (ePRO)/diary assessments
- Willingness to utilize the activity tracking device
Who cannot join
- Current diagnosis of a FVIII inhibitor, defined as inhibitor titer ≥ 0.60 BU/mL
- Use of efanesoctocog alfa for prophylaxis in the 6 months prior to enrollment
- NOTE: Other Inclusion/Exclusion criteria may apply. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bleeding and Clotting Disorders Institute
Peoria, Illinois, 61614
About this study
Official title: Prospective, Observational Study of the Impact of Efanesoctocog Alfa (ALTUVIIIO®) on Goal Attainment and Physical Activity in People With Moderate or Severe Hemophilia A
This is a Phase 4, multi-center, observational study conducted in patients aged 12 to 50 years with moderate or severe hemophilia A who are newly starting prophylaxis with efa in the US and Japan.
This study aims to enroll 35 patients.
- Conditions
- Hemophilia A
- Being tested
- efanesoctocog alfa
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
efanesoctocog alfaDrug
Also called Altuviiio
All treatment decisions must be made independent of study participation and study-related visits/assessments are not intended to inform treatment decisions. No study medication is provided as part of study participation.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | patients aged 12 to 50 years with moderate or severe hemophilia A who are newly starting prophylaxis with efa Receives: Drug: efanesoctocog alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of total goals achieved
Reported as number of individual goals with a raw GAS score of 0, +1, or +2 divided by the total number of goals set
Measured: Month 3
Proportion of total goals achieved
Measured: Month 6
Proportion of total goals achieved
Measured: Month 9
Proportion of total goals achieved
Measured: Month 12
Proportion of patients who reached a +2 or +1 on at least one goal
Each goal will be ranked in a 5-point Likert scale ranging from +2 to -2 with +2 indicating a better goal achievement.
Measured: Month 3
Proportion of patients who reached a +2 or +1 on at least one goal
Measured: Month 6
Proportion of patients who reached a +2 or +1 on at least one goal
Measured: Month 9
Proportion of patients who reached a +2 or +1 on at least one goal
Measured: Month 12
Overall GAS score
Goal Attainment Scaling (GAS) is a patient-centric clinician-reported outcome measure utilized to select and scale goals, with higher scores indicating greater goal attainment.
An overall GAS score utilizing all goals set by a patient at each time point of interest will be calculated.
Measured: Month 3
Overall GAS score
Goal Attainment Scaling (GAS) is a patient-centric clinician-reported outcome measure utilized to select and scale goals, with higher scores indicating greater goal attainment.
An overall GAS score utilizing all goals set by a patient at each time point of interest will be calculated.
Measured: Month 6
Overall GAS score
Goal Attainment Scaling (GAS) is a patient-centric clinician-reported outcome measure utilized to select and scale goals, with higher scores indicating greater goal attainment.
An overall GAS score utilizing all goals set by a patient at each time point of interest will be calculated.
Measured: Month 9
Overall GAS score
Goal Attainment Scaling (GAS) is a patient-centric clinician-reported outcome measure utilized to select and scale goals, with higher scores indicating greater goal attainment.
An overall GAS score utilizing all goals set by a patient at each time point of interest will be calculated.
Measured: Month 12
Frequency of selection of category of physical activity
Categories of the goals selected from the goal inventory
Measured: Baseline
Monthly average of daily step count
The monthly average of daily step count (recorded by physical tracker) will be calculated using the total steps recorded in a 30-day period, accounting for the number of compliant days in that period.
Measured: From Baseline to Month 12
Monthly average of daily activity count
Activity count includes: time spent in x, y, and z axes, vector magnitude counts, estimated calories, wear time, time spent in locomotion and non-locomotion. Counts will be averaged across the month.
Measured: From Baseline to Month 12
Monthly average of daily Metabolic equivalent of tasks (MET)
Estimated by the physical activity tracker
Measured: From Baseline to Month 12
Monthly average of daily Moderate and Vigorous Physical Activity (MVPA)
Summarized from MET data with time spent in moderate intensity, and vigorous intensity physical activity
Measured: From Baseline to Month 12
Monthly average of daily intensity gradient
The intensity gradient is a measure of activity intensity distribution that reflects the distribution of intensity of physical activity by modeling the relationship between intensity and time.
Measured: From Baseline to Month 12
Monthly average of weekly intensity gradient
Measured: From Baseline to Month 12
Secondary outcomes (31)
Change in PROMIS Pain intensity score
Patient-Reported Outcome Measurement Information System (PROMIS): assessment of pain over the prior 7-day period (2 of the 3 questions) and right now (1 of the 3 questions), with patients rating their pain on a scale of 0 (had no pain) to 5 (very severe). Total score ranges from 0 to 15 and a higher score indicates worst pain intensity.
Measured: From Baseline to Month 12
Change in HAL Score
Hemophilia Activities List (HAL) is a 42-item questionnaire to access patient ability across 7 domains: lying down/ sitting/ kneeling/ standing (8 items), functions of the legs (9 items), functions of the arms (4 items), use of transportation (3 items), self-care (5 items), household tasks (6 items), and leisure activities (7 items). Patients rate each question on a Likert scale ranging from 1 (impossible) to 6 (never). Several items have a "not applicable" option as well. There is also a visual analog scale allowing patients to self-report an overall score. A normalized total score (sum of all normalized domains) ranges from 0 (the worst possible functional status) to 100 (the best possible functional status)
Measured: From Baseline to Month 12
Change in PROMIS pediatric Pain intensity score
Assessment of the average pain over the prior 7-day period, with patients rating their pain on a scale of 0 (no pain) to 10 (worst pain they can think of). A higher score indicates worst pain intensity.
Measured: From Baseline to Month 12
Change in PedHAL Score
Pediatric Hemophilia Activities List (PedHAL) is a 53-item questionnaire to access patient functional ability across 7 domains: lying down/ sitting/ kneeling/ standing (10 items), functions of the legs (11 items), functions of the arms (6 items), use of transportation (3 items), self-care (9 items), household tasks (3 items), and leisure activities and sports (11 items). Patients rate each question on a Likert scale ranging from 1 (impossible) to 6 (never). Several items have a "not applicable" option as well. There is also a visual analog scale allowing patients to self-report an overall score. A normalized total score (sum of all normalized domains) ranges from 0 (the worst possible functional status) to 100 (the best possible functional status).
Measured: From Baseline to Month 12
Change in school/work hours missed as assessed by WPAI+CIQ:HS
The Work Productivity and Activity Impairment plus Classroom Impairment Questions: Hemophilia Specific (WPAI + CIQ: HS) is a 9-item questionnaire assessing the effect of hemophilia on patients' ability to work and/or attend classes.
Measured: From Baseline to Month 12
Change in productivity as assessed by WPAI+CIQ:HS
The Work Productivity and Activity Impairment plus Classroom Impairment Questions: Hemophilia Specific (WPAI + CIQ: HS) is a 9-item questionnaire assessing the effect of hemophilia on patients' ability to perform regular daily activities.
Measured: From Baseline to Month 12
Change in impact on other activities as assessed by WPAI+CIQ:HS
The Work Productivity and Activity Impairment plus Classroom Impairment Questions: Hemophilia Specific (WPAI + CIQ: HS) is a 9-item questionnaire assessing the effect of hemophilia on patients' ability to perform other activities.
Measured: From Baseline to 12 months
Mean change in total and joint domain scores of HJHS
The Hemophilia Joint Health Score (HJHS) assesses 6 index joints (left and right elbows, knees and ankles) and a global gait. For each of the 6 joints, the following items are scored: swelling (scored 0-3), duration of swelling (0-1), muscle atrophy (0-2), crepitus on motion (0-2), flexion loss (0-3), extension loss (0-3), joint pain (0-2), and strength (0-4). The HJHS provides a total score (0-124 points with higher score indicating worse joint health), joint specific scores (0-20 points), and a global gait score (0-4 points).
Measured: From Baseline to 12 months
Monthly total and average of daily time spent in different intensity levels
Physical activity intensity defined as sedentary behavior, light intensity, moderate intensity, and vigorous intensity,
Measured: From Baseline to Month 12
Monthly average of daily median activity count overall among moderate activities and among vigorous activities
Daily median time spent in moderate and vigorous physical activity will be averaged across the month
Measured: From Baseline to Month 12
Monthly average of daily median MET overall among moderate activities and among vigorous activities
Measured: From Baseline to Month 12
Monthly average of weekly power law exponent alpha
Measured: From Baseline to Month 12
Monthly average of median bout length and percent of time of bout length > median bout length for each intensity level
Measured: From Baseline to Month 12
Monthly average of weekly 80th, 90th, 95th, and 100th percentiles of activity count
Measured: From Baseline to Month 12
Monthly average of weekly 80th, 90th, 95th, and 100th percentiles of MET
Measured: From Baseline to Month 12
Monthly total step count
Measured: From Baseline to Month 12
Monthly total activity count
Activity count includes: time spent in x, y, and z axes, vector magnitude counts, estimated calories, wear time, time spent in locomotion and non-locomotion. Counts will be totaled across the month.
Measured: From Baseline to Month 12
Monthly total MET
Measured: From Baseline to Month 12
Monthly total moderate or vigorous physical activity (MVPA)
Time spent in MVPA will be totaled across the month.
Measured: From Baseline to Month 12
Weekly average of daily step count
Measured: From Baseline to Month 12
Weekly average of daily activity count
Activity count includes: time spent in x, y, and z axes, vector magnitude counts, estimated calories, wear time, time spent in locomotion and non-locomotion. Counts will be averaged across the week.
Measured: From Baseline to Month 12
Weekly average of daily MET
Measured: From Baseline to Month 12
Weekly average of daily MVPA
Time spent in MVPA will be averaged across the week.
Measured: From Baseline to Month 12
Weekly average of daily intensity gradient
Measured: From Baseline to Month 12
Weekly intensity gradient
Measured: From Baseline to Month 12
Number of participants with AE, SAEs, AESIs
Measured: Baseline to end of study (12 months)
Number of participants with AEs, SAEs, AESIs related to efanesoctocog alfa
Measured: Baseline to end of study (12 months)
Proportion of total planned doses that were missed
Measured: From baseline to end of study (12 months)
Average time between treatment dose and physical activity
Measured: From baseline to end of study (12 months)
Number of patients with no reported bleeds requiring treatment
Measured: From baseline to end of study (12 months)
Average number of per patient treatment doses administered for treatment of bleeds
Measured: From baseline to end of study (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start26 Nov 2024
- Primary completion18 Sep 2025
- Study completion18 Sep 2025
Why it stopped: Early discontinuation based on sponsor decision not driven by any safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06530030
- Sponsor's protocol ID
- OBS18140
- Other IDs
- U1111-1306-7241
- Acronym
- ACTIVIIITY
- Status last verified
- Jan 2026
- First submitted
- 17 Jul 2024
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational Study of the Impact of Efanesoctocog Alfa (ALTUVIIIO®) on Goal Attainment and Physical Activity in People With Moderate or Severe Hemophilia A
- ClinicalTrials.gov ID
- NCT06530030
- Acronym / sponsor ID
- ACTIVIIITY / OBS18140
- Conditions
- Hemophilia A
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Early discontinuation based on sponsor decision not driven by any safety concerns.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- 18 Sep 2025 (actual)
- Study completion
- 18 Sep 2025 (actual)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 4, multi-center, observational study conducted in patients aged 12 to 50 years with moderate or severe hemophilia A who are newly starting prophylaxis with efa in the US and Japan.
This study aims to enroll 35 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Drug: efanesoctocog alfapatients aged 12 to 50 years with moderate or severe hemophilia A who are newly starting prophylaxis with efa |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with moderate or severe Hemophilia A
Key inclusion criteria (6 listed)
- At enrollment, newly starting prophylaxis therapy with efanesoctocog alfa according to usual clinical practice, with efanesoctocog alfa initiated within 6 months after the enrollment visit
- Diagnosis of moderate (endogenous FVIII activity between 1% to 5% of normal) or severe (endogenous FVIII activity <1% of normal) hemophilia A
- Aged 12 to 50 years at time of enrollment, inclusive
- Access to a smartphone device (Android version 12.0 or higher; or iOS 13 or higher) with Bluetooth 4.0 (minimum) or 5.0 (recommended) capabilities for compatibility with physical activity tracker
- Availability of home-based access to internet for electronic patient-reported outcome (ePRO)/diary assessments
Key exclusion criteria (3 listed)
- Current diagnosis of a FVIII inhibitor, defined as inhibitor titer ≥ 0.60 BU/mL
- Use of efanesoctocog alfa for prophylaxis in the 6 months prior to enrollment
- NOTE: Other Inclusion/Exclusion criteria may apply. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| efanesoctocog alfaAlso: AltuviiioAll treatment decisions must be made independent of study participation and study-related visits/assessments are not intended to inform treatment decisions. No study medication is provided as part of study participation. | Drug | Cohort |
Primary outcome
Proportion of total goals achieved
Time frame: Month 3
Reported as number of individual goals with a raw GAS score of 0, +1, or +2 divided by the total number of goals set
Proportion of total goals achieved
Time frame: Month 6
Proportion of total goals achieved
Time frame: Month 9
Proportion of total goals achieved
Time frame: Month 12
Proportion of patients who reached a +2 or +1 on at least one goal
Time frame: Month 3
Each goal will be ranked in a 5-point Likert scale ranging from +2 to -2 with +2 indicating a better goal achievement.
Proportion of patients who reached a +2 or +1 on at least one goal
Time frame: Month 6
Proportion of patients who reached a +2 or +1 on at least one goal
Time frame: Month 9
Proportion of patients who reached a +2 or +1 on at least one goal
Time frame: Month 12
Overall GAS score
Time frame: Month 3
Goal Attainment Scaling (GAS) is a patient-centric clinician-reported outcome measure utilized to select and scale goals, with higher scores indicating greater goal attainment. An overall GAS score utilizing all goals set by a patient at each time point of interest will be calculated.
Overall GAS score
Time frame: Month 6
Goal Attainment Scaling (GAS) is a patient-centric clinician-reported outcome measure utilized to select and scale goals, with higher scores indicating greater goal attainment. An overall GAS score utilizing all goals set by a patient at each time point of interest will be calculated.
Overall GAS score
Time frame: Month 9
Goal Attainment Scaling (GAS) is a patient-centric clinician-reported outcome measure utilized to select and scale goals, with higher scores indicating greater goal attainment. An overall GAS score utilizing all goals set by a patient at each time point of interest will be calculated.
Overall GAS score
Time frame: Month 12
Goal Attainment Scaling (GAS) is a patient-centric clinician-reported outcome measure utilized to select and scale goals, with higher scores indicating greater goal attainment. An overall GAS score utilizing all goals set by a patient at each time point of interest will be calculated.
Frequency of selection of category of physical activity
Time frame: Baseline
Categories of the goals selected from the goal inventory
Monthly average of daily step count
Time frame: From Baseline to Month 12
The monthly average of daily step count (recorded by physical tracker) will be calculated using the total steps recorded in a 30-day period, accounting for the number of compliant days in that period.
Monthly average of daily activity count
Time frame: From Baseline to Month 12
Activity count includes: time spent in x, y, and z axes, vector magnitude counts, estimated calories, wear time, time spent in locomotion and non-locomotion. Counts will be averaged across the month.
Monthly average of daily Metabolic equivalent of tasks (MET)
Time frame: From Baseline to Month 12
Estimated by the physical activity tracker
Monthly average of daily Moderate and Vigorous Physical Activity (MVPA)
Time frame: From Baseline to Month 12
Summarized from MET data with time spent in moderate intensity, and vigorous intensity physical activity
Monthly average of daily intensity gradient
Time frame: From Baseline to Month 12
The intensity gradient is a measure of activity intensity distribution that reflects the distribution of intensity of physical activity by modeling the relationship between intensity and time.
Monthly average of weekly intensity gradient
Time frame: From Baseline to Month 12
31 secondary outcomes
Change in PROMIS Pain intensity score
Time frame: From Baseline to Month 12
Change in HAL Score
Time frame: From Baseline to Month 12
Change in PROMIS pediatric Pain intensity score
Time frame: From Baseline to Month 12
Change in PedHAL Score
Time frame: From Baseline to Month 12
Change in school/work hours missed as assessed by WPAI+CIQ:HS
Time frame: From Baseline to Month 12
Change in productivity as assessed by WPAI+CIQ:HS
Time frame: From Baseline to Month 12
Change in impact on other activities as assessed by WPAI+CIQ:HS
Time frame: From Baseline to 12 months
Mean change in total and joint domain scores of HJHS
Time frame: From Baseline to 12 months
Monthly total and average of daily time spent in different intensity levels
Time frame: From Baseline to Month 12
Monthly average of daily median activity count overall among moderate activities and among vigorous activities
Time frame: From Baseline to Month 12
Monthly average of daily median MET overall among moderate activities and among vigorous activities
Time frame: From Baseline to Month 12
Monthly average of weekly power law exponent alpha
Time frame: From Baseline to Month 12
Monthly average of median bout length and percent of time of bout length > median bout length for each intensity level
Time frame: From Baseline to Month 12
Monthly average of weekly 80th, 90th, 95th, and 100th percentiles of activity count
Time frame: From Baseline to Month 12
Monthly average of weekly 80th, 90th, 95th, and 100th percentiles of MET
Time frame: From Baseline to Month 12
Monthly total step count
Time frame: From Baseline to Month 12
Monthly total activity count
Time frame: From Baseline to Month 12
Monthly total MET
Time frame: From Baseline to Month 12
Monthly total moderate or vigorous physical activity (MVPA)
Time frame: From Baseline to Month 12
Weekly average of daily step count
Time frame: From Baseline to Month 12
Weekly average of daily activity count
Time frame: From Baseline to Month 12
Weekly average of daily MET
Time frame: From Baseline to Month 12
Weekly average of daily MVPA
Time frame: From Baseline to Month 12
Weekly average of daily intensity gradient
Time frame: From Baseline to Month 12
Weekly intensity gradient
Time frame: From Baseline to Month 12
Number of participants with AE, SAEs, AESIs
Time frame: Baseline to end of study (12 months)
Number of participants with AEs, SAEs, AESIs related to efanesoctocog alfa
Time frame: Baseline to end of study (12 months)
Proportion of total planned doses that were missed
Time frame: From baseline to end of study (12 months)
Average time between treatment dose and physical activity
Time frame: From baseline to end of study (12 months)
Number of patients with no reported bleeds requiring treatment
Time frame: From baseline to end of study (12 months)
Average number of per patient treatment doses administered for treatment of bleeds
Time frame: From baseline to end of study (12 months)
Results and safety
The study was stopped early (reason given: Early discontinuation based on sponsor decision not driven by any safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia A, run by Sanofi at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Early discontinuation based on sponsor decision not driven by any safety concerns.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of total goals achieved (time frame: Month 3). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.