Hemophilia APROTECT-ALTNCT06684314
A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A in Taiwan
An observational study of Hemophilia A, run by Sanofi at 10 sites in Taiwan.
Trial summary
This is a national, multicenter, retrospective/prospective, observational study in Taiwan designed to assess effectiveness, safety, and usage of efanesoctocog alfa prophylaxis treatment in hemophilia A participants. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemophilia A
- What is being tested?
- Efanesoctocog alfa
- How many people
- 79 participants
- Where
- 10 sitesTaiwan
- Study dates
- 11 Nov 2024to 28 Aug 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants from medical centers in Taiwan will be enrolled in the study after the introduction of efanesoctocog alfa for the treatment of hemophilia A. Eligible participants will include all ages, sexes and moderate to severe hemophilia A severities under efanesoctocog alfa prophylaxis treatment and able to undergo joint and/or MRI examinations during routine clinical practice.
Who may be able to join
- Participants with all ages and diagnosis of moderate-severe hemophilia A without current and/or at least three years of un-detectable inhibitor (<0.6 BU)
- Participants with moderate to severe hemophilia A as defined by FVIII level ≤ 5%
- Participants starting efanesoctocog alfa prophylaxis treatment as per standard of care no more than three months prior to the enrollment date
- Participants aged 6 years and older are able to undergo MRI examinations (sedation given, if necessary, and per investigator discretion)
- Participants are able to undergo joint examinations
- Physician's decision to treat the participant with efanesoctocog alfa is made prior to and independently of participation in the study
- Signed and dated informed consent provided by the participant, or by the participant's legally acceptable representative for participants under the legal age before any study-related activities are undertaken. Assent should be obtained for pediatric participants according to local regulations
Who cannot join
- Participants with coagulation disorders other than hemophilia A
- Participants diagnosed with other known bleeding disorder
- Participants currently receive factor therapy and have signs of decreased response to FVIII therapy
- Participants with a baseline Radiological Pettersson score (PS) of greater than 6 for each individual ankle
- Enrollment in another concurrent clinical interventional study, or intake of an Investigational Medicinal Product within 3 months prior to inclusion in this study
- Pregnant female participants
- The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Taiwan10 sites
Investigational Site Number : 1580008
Changhua, 500
Investigational Site Number : 1580009
Kaohsiung City, 80756
Investigational Site Number : 1580010
Kaohsiung City, 833
Investigational Site Number : 1580003
New Taipei City, 235
Investigational Site Number : 1580005
Taichung, 402
Investigational Site Number : 1580006
Taichung, 404
Investigational Site Number : 1580007
Taichung, 407
Investigational Site Number : 1580001
Taipei, 100
Investigational Site Number : 1580002
Taipei, 114
Investigational Site Number : 1580004
Taoyuan City, 333
About this study
Official title: PROphylactic Efanesoctocog Alfa Therapy Evaluated for Critical Joint Health in Hemophilia A Treatment: The PROTECT-ALT Study
This is a national, multicenter, retrospective/prospective, observational study in Taiwan designed to assess effectiveness, safety, and usage of efanesoctocog alfa prophylaxis treatment in hemophilia A participants. The data related to efanesoctocog alfa effectiveness, safety and usage will be recorded prospectively during routine visits for up to 5 years following enrollment initiation and the retrospective data will be collected at least 12 months and up to 24 months prior to efanesoctocog alfa initiation. Joint imaging data will be collected in centers performing Joint U/S and/or MRI (≥6 years old). At least 12 months of retrospective data will also be collected from medical records, as available. Prospectively collected data will be recorded at routine clinical visits during a five-year follow-up period. The end of study is defined as the last participant's last visit. No intervention will be administered, and no study related visits are required.
- Conditions
- Hemophilia A
- Being tested
- Efanesoctocog alfa
- Keywords
- Classic Hemophilia, Factor VIII Deficiency, Haemophilia, Hemophilia, Hemarthrosis, Blood Coagulation Disorders, Inherited, Hematologic Diseases, Coagulation Protein Disorders, Hemorrhagic Disorders, Genetic Diseases, Inborn
- Medical subject headings
- Hemophilia A, Hemarthrosis, Blood Coagulation Disorders, Inherited, Hematologic Diseases, Coagulation Protein Disorders, Hemorrhagic Disorders, Genetic Diseases, Inborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Efanesoctocog alfaDrug
Also called ALTUVIIIO, BIVV001
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practices.
| Study group | Role | What they receive |
|---|---|---|
| Efanesoctocog alfa | Participants observed receiving treatment with efanesoctocog alfa for hemophilia A Receives: Drug: Efanesoctocog alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in total scores of the Hemophilia Joint Health Score (HJHS) for all joints
The HJHS summarizes joint health by providing a clinical score in the domain of body structure and function (i.e., impairment), of the joints most commonly affected by bleeding in hemophilia: (left ankle, right ankle, left elbow, right elbow, left knee, right knee). The HJHS consists of assessments of swelling, duration of swelling, muscle atrophy, crepitus on motion, flexion loss, extension loss, joint pain and strength for elbows, knees and ankles and a global gait score. A higher score indicates worse joint health.
Measured: At 1, 2, 3, 4 and 5 years
Change from baseline in annualized joint bleeding rate (AjBR) for treated and untreated bleeds
The AjBR is defined as the number of joint bleeding episodes occurring during the treatment period divided by the duration of the treatment period in days multiplied by 365.25. All types of joint bleeding episodes (spontaneous, traumatic, and type unknown) will be included in determining the annualized number.
Measured: At 1, 2, 3, 4 and 5 years
Number of target joint development, resolution and/or recurrence
Measured: At 1, 2 ,3, 4 and 5 years
Secondary outcomes (37)
Annualized bleeding rate (ABR) by type and location for treated and all (treated and untreated) bleeds
Measured: At 1, 2, 3, 4 and 5 years
ABR for all bleeding episodes, including untreated bleeding episodes
Measured: At 1, 2, 3, 4 and 5 years
Percentage of participants with zero joint bleeds
Measured: At 1, 2, 3, 4 and 5 years
Percentage of bleeding episodes treated with a single injection of efanesoctocog alfa
Measured: At 1, 2, 3, 4 and 5 years
Number of injections and doses of efanesoctocog alfa to treat a bleeding episode
Measured: At 1, 2, 3, 4 and 5 years
Annualized factor consumption per participant (IU/kg) assessed by prescription during the follow-up period
Measured: At 1, 2, 3, 4 and 5 years
Annualized injection frequency per participant (assessed by prescription) during the followup period
Measured: At 1, 2, 3, 4 and 5 years
Treatment adherence (%) as judged by the physician during the follow-up period
Measured: At 1, 2, 3, 4 and 5 years
Occurrence of a change in treatment regimen at baseline and follow-up
Measured: 5 years
Change from baseline in Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) total/domain scores in all joints
Measured: Every 6 months for 5 years
Change from baseline in joint status on functional HJHS
Measured: At 1, 2, 3, 4 and 5 years
Number and percentage of joints with no prior joint damage at baseline, without joint damage on joint ultrasound
Measured: At 5 years
Changes from baseline in HEAD-US synovitis domain
Measured: Every 6 months for 5 years
Change from baseline in MRI score
Measured: At 1, 2, 3, 4 and 5 years
Number and percentage of participants without joint damage on MRI
Measured: At 1, 2, 3, 4 and 5 years
Number and percentage of joints with no prior joint damage at baseline, without joint damage on MRI
Measured: At 1, 2, 3, 4 and 5 years
Hemostatic response/physician reported during peri-operative period for surgery (major, minor) with efanesoctocog alfa
Measured: 5 years
Number of injections and dose per injection required to maintain hemostasis during perioperative period for surgery (major, minor)
Measured: 5 years
Total efanesoctocog alfa consumption (IU) during perioperative period for surgery (major, minor)
Measured: 5 years
Number and type of blood component transfusions used during perioperative period for surgery
Measured: 5 years
Estimated blood loss (mL) during perioperative period for major surgery
Measured: 5 years
Number of transfusions required for surgery (intraoperative and post-operative period)
Measured: 5 years
Duration of hospitalization (major, minor)
Measured: 5 years
Occurrence of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESI)
Measured: 5 years
Development of inhibitors (neutralizing antibodies directed against factor FVIII as determined via the Nijmegen modified Bethesda assay)
Measured: 5 years
Change from baseline in HAL (haemophilia activities list) for adult participants only
HAL contains 42 items across 7 domains: lying down/ sitting/ kneeling/ standing, functions of the legs, functions of the arms, use of transportation, self-care, household tasks and leisure activities and sports. Items are scored on a 6-point Likert scale ('impossible', 'always', 'usually', 'sometimes', 'almost never', 'never'), with a 'not applicable' option for some items. A summary score as well as component scores (upper extremity, basic lower extremity and complex lower extremity) can be calculated. The scores are converted to a normalized score from 0 to 100, where higher scores represent a better functional status.
Measured: At 1, 2, 3, 4 and 5 years
Change from baseline in PROMIS pain intensity 3a questionnaire for adult participants only
The PROMIS Pain Intensity instrument assesses how much a person hurts. The Pain Intensity short forms are universal rather than disease specific. The 1a and the first two items within the PROMIS Scale- Pain Intensity 3a short form assesses pain intensity over the past seven days. The version 2.0 of Pain Intensity 3a instruments are available for adults (ages 18+), and the version v1.0 of Pediatric Pain Intensity 1a self-report (ages 8-17) will be used for this study.
Measured: At 1, 2, 3, 4 and 5 years
Change from baseline in PROBE full questionnaire for adult participants only
The PROBE questionnaire assesses participant reported outcomes in people with hemophilia and people without a bleeding disorder. The PROBE questionnaire is comprised of four major sections, including demographic data, general health problems, hemophilia-related health problems and health-related quality of life. It combines generic and disease-specific outcomes in 29 questions.
Measured: At 1, 2, 3, 4 and 5 years
Change from baseline in Ped-HAL (haemophilia activities list) for adolescent participants only (≥ 12 to <18 years)
PedHAL contains 53 items across 7 domains: sitting/ kneeling/ standing, functions of the legs, functions of the arms, use of transportation, self-care, household tasks and leisure activities and sports. It consists of a participant version (8-18 years) and parent version (4-17 years). Items are scored on a 6-point Likert scale ('impossible', 'always', 'usually', 'sometimes', 'almost never', 'never'), with a 'not applicable (N/A)' scoring option for all items. A summary score as well as domain scores can be calculated. The scores are converted to a normalized score from 0 to 100, where higher scores represent a better functional status.
Measured: At 1, 2, 3, 4 and 5 years
Change from baseline in PROMIS pain intensity 1a questionnaire for adolescent participants only (≥ 12 to <18 years)
The PROMIS Pain Intensity instrument assesses how much a person hurts. The Pain Intensity short forms are universal rather than disease specific. The 1a and the first two items within the PROMIS Scale- Pain Intensity 3a short form assesses pain intensity over the past seven days. The version 2.0 of Pain Intensity 3a instruments are available for adults (ages 18+), and the version v1.0 of Pediatric Pain Intensity 1a self-report (ages 8-17) will be used for this study.
Measured: At 1, 2, 3, 4 and 5 years
Change from baseline in PROBE full questionnaire for adolescent participants only (≥ 12 to <18 years)
The PROBE questionnaire assesses participant reported outcomes in people with hemophilia and people without a bleeding disorder. The PROBE questionnaire is comprised of four major sections, including demographic data, general health problems, hemophilia-related health problems and health-related quality of life. It combines generic and disease-specific outcomes in 29 questions.
Measured: At 1, 2, 3, 4 and 5 years
Change from baseline in Ped-HAL (pediatric haemophilia activities list) for pediatric participants only (12 years and younger)
PedHAL contains 53 items across 7 domains: sitting/ kneeling/ standing, functions of the legs, functions of the arms, use of transportation, self-care, household tasks and leisure activities and sports. It consists of a participant version (8-18 years) and parent version (4-17 years). Items are scored on a 6-point Likert scale ('impossible', 'always', 'usually', 'sometimes', 'almost never', 'never'), with a 'not applicable (N/A)' scoring option for all items. A summary score as well as domain scores can be calculated. The scores are converted to a normalized score from 0 to 100, where higher scores represent a better functional status.
Measured: At 1, 2, 3, 4 and 5 years
Number of hospitalizations excluding surgery and admission/discharge diagnoses
Measured: Change from baseline at 1, 2, 3, 4 and 5 years
Number of hospitalization days
Measured: Change from baseline at 1, 2, 3, 4 and 5 years
Number of intensive care unit (ICU) stays
Measured: Change from baseline at 1, 2, 3, 4 and 5 years
Number of emergency room visits
Measured: Change from baseline at 1, 2, 3, 4 and 5 years
Number of outpatient visits
Measured: Change from baseline at 1, 2, 3, 4 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start11 Nov 2024
- Primary completion28 Aug 2031 (estimated)
- Study completion28 Aug 2031 (estimated)
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
- Other
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684314
- Sponsor's protocol ID
- OBS18067
- Other IDs
- U1111-1308-9835
- Acronym
- PROTECT-ALT
- Status last verified
- Sep 2026
- First submitted
- 8 Nov 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- 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 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROphylactic Efanesoctocog Alfa Therapy Evaluated for Critical Joint Health in Hemophilia A Treatment: The PROTECT-ALT Study
- ClinicalTrials.gov ID
- NCT06684314
- Acronym / sponsor ID
- PROTECT-ALT / OBS18067
- Conditions
- Hemophilia A
- Keywords
- Classic Hemophilia, Factor VIII Deficiency, Haemophilia, Hemophilia, Hemarthrosis, Blood Coagulation Disorders, Inherited, Hematologic Diseases, Coagulation Protein Disorders
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 79 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 28 Aug 2031 (estimated)
- Study completion
- 28 Aug 2031 (estimated)
- First posted
- 12 Nov 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 national, multicenter, retrospective/prospective, observational study in Taiwan designed to assess effectiveness, safety, and usage of efanesoctocog alfa prophylaxis treatment in hemophilia A participants. The data related to efanesoctocog alfa effectiveness, safety and usage will be recorded prospectively during routine visits for up to 5 years following enrollment initiation and the retrospective data will be collected at least 12 months and up to 24 months prior to efanesoctocog alfa initiation. Joint imaging data will be collected in centers performing Joint U/S and/or MRI (≥6 years old). At least 12 months of retrospective data will also be collected from medical records, as available. Prospectively collected data will be recorded at routine clinical visits during a five-year follow-up period. The end of study is defined as the last participant's last visit. No intervention will be administered, and no study related visits are required.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Efanesoctocog alfa | – | Drug: Efanesoctocog alfaParticipants observed receiving treatment with efanesoctocog alfa for hemophilia A |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants from medical centers in Taiwan will be enrolled in the study after the introduction of efanesoctocog alfa for the treatment of hemophilia A. Eligible participants will include all ages, sexes and moderate to severe hemophilia A severities under efanesoctocog alfa prophylaxis treatment and able to undergo joint and/or MRI examinations during routine clinical practice.
Key inclusion criteria (7 listed)
- Participants with all ages and diagnosis of moderate-severe hemophilia A without current and/or at least three years of un-detectable inhibitor (<0.6 BU)
- Participants with moderate to severe hemophilia A as defined by FVIII level ≤ 5%
- Participants starting efanesoctocog alfa prophylaxis treatment as per standard of care no more than three months prior to the enrollment date
- Participants aged 6 years and older are able to undergo MRI examinations (sedation given, if necessary, and per investigator discretion)
- Participants are able to undergo joint examinations
Key exclusion criteria (7 listed)
- Participants with coagulation disorders other than hemophilia A
- Participants diagnosed with other known bleeding disorder
- Participants currently receive factor therapy and have signs of decreased response to FVIII therapy
- Participants with a baseline Radiological Pettersson score (PS) of greater than 6 for each individual ankle
- Enrollment in another concurrent clinical interventional study, or intake of an Investigational Medicinal Product within 3 months prior to inclusion in this study
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: ALTUVIIIO, BIVV001This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practices. | Drug | Efanesoctocog alfa |
Primary outcome
Change from baseline in total scores of the Hemophilia Joint Health Score (HJHS) for all joints
Time frame: At 1, 2, 3, 4 and 5 years
The HJHS summarizes joint health by providing a clinical score in the domain of body structure and function (i.e., impairment), of the joints most commonly affected by bleeding in hemophilia: (left ankle, right ankle, left elbow, right elbow, left knee, right knee). The HJHS consists of assessments of swelling, duration of swelling, muscle atrophy, crepitus on motion, flexion loss, extension loss, joint pain and strength for elbows, knees and ankles and a global gait score. A higher score indicates worse joint health.
Change from baseline in annualized joint bleeding rate (AjBR) for treated and untreated bleeds
Time frame: At 1, 2, 3, 4 and 5 years
The AjBR is defined as the number of joint bleeding episodes occurring during the treatment period divided by the duration of the treatment period in days multiplied by 365.25. All types of joint bleeding episodes (spontaneous, traumatic, and type unknown) will be included in determining the annualized number.
Number of target joint development, resolution and/or recurrence
Time frame: At 1, 2 ,3, 4 and 5 years
37 secondary outcomes
Annualized bleeding rate (ABR) by type and location for treated and all (treated and untreated) bleeds
Time frame: At 1, 2, 3, 4 and 5 years
ABR for all bleeding episodes, including untreated bleeding episodes
Time frame: At 1, 2, 3, 4 and 5 years
Percentage of participants with zero joint bleeds
Time frame: At 1, 2, 3, 4 and 5 years
Percentage of bleeding episodes treated with a single injection of efanesoctocog alfa
Time frame: At 1, 2, 3, 4 and 5 years
Number of injections and doses of efanesoctocog alfa to treat a bleeding episode
Time frame: At 1, 2, 3, 4 and 5 years
Annualized factor consumption per participant (IU/kg) assessed by prescription during the follow-up period
Time frame: At 1, 2, 3, 4 and 5 years
Annualized injection frequency per participant (assessed by prescription) during the followup period
Time frame: At 1, 2, 3, 4 and 5 years
Treatment adherence (%) as judged by the physician during the follow-up period
Time frame: At 1, 2, 3, 4 and 5 years
Occurrence of a change in treatment regimen at baseline and follow-up
Time frame: 5 years
Change from baseline in Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) total/domain scores in all joints
Time frame: Every 6 months for 5 years
Change from baseline in joint status on functional HJHS
Time frame: At 1, 2, 3, 4 and 5 years
Number and percentage of joints with no prior joint damage at baseline, without joint damage on joint ultrasound
Time frame: At 5 years
Changes from baseline in HEAD-US synovitis domain
Time frame: Every 6 months for 5 years
Change from baseline in MRI score
Time frame: At 1, 2, 3, 4 and 5 years
Number and percentage of participants without joint damage on MRI
Time frame: At 1, 2, 3, 4 and 5 years
Number and percentage of joints with no prior joint damage at baseline, without joint damage on MRI
Time frame: At 1, 2, 3, 4 and 5 years
Hemostatic response/physician reported during peri-operative period for surgery (major, minor) with efanesoctocog alfa
Time frame: 5 years
Number of injections and dose per injection required to maintain hemostasis during perioperative period for surgery (major, minor)
Time frame: 5 years
Total efanesoctocog alfa consumption (IU) during perioperative period for surgery (major, minor)
Time frame: 5 years
Number and type of blood component transfusions used during perioperative period for surgery
Time frame: 5 years
Estimated blood loss (mL) during perioperative period for major surgery
Time frame: 5 years
Number of transfusions required for surgery (intraoperative and post-operative period)
Time frame: 5 years
Duration of hospitalization (major, minor)
Time frame: 5 years
Occurrence of adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESI)
Time frame: 5 years
Development of inhibitors (neutralizing antibodies directed against factor FVIII as determined via the Nijmegen modified Bethesda assay)
Time frame: 5 years
Change from baseline in HAL (haemophilia activities list) for adult participants only
Time frame: At 1, 2, 3, 4 and 5 years
Change from baseline in PROMIS pain intensity 3a questionnaire for adult participants only
Time frame: At 1, 2, 3, 4 and 5 years
Change from baseline in PROBE full questionnaire for adult participants only
Time frame: At 1, 2, 3, 4 and 5 years
Change from baseline in Ped-HAL (haemophilia activities list) for adolescent participants only (≥ 12 to <18 years)
Time frame: At 1, 2, 3, 4 and 5 years
Change from baseline in PROMIS pain intensity 1a questionnaire for adolescent participants only (≥ 12 to <18 years)
Time frame: At 1, 2, 3, 4 and 5 years
Change from baseline in PROBE full questionnaire for adolescent participants only (≥ 12 to <18 years)
Time frame: At 1, 2, 3, 4 and 5 years
Change from baseline in Ped-HAL (pediatric haemophilia activities list) for pediatric participants only (12 years and younger)
Time frame: At 1, 2, 3, 4 and 5 years
Number of hospitalizations excluding surgery and admission/discharge diagnoses
Time frame: Change from baseline at 1, 2, 3, 4 and 5 years
Number of hospitalization days
Time frame: Change from baseline at 1, 2, 3, 4 and 5 years
Number of intensive care unit (ICU) stays
Time frame: Change from baseline at 1, 2, 3, 4 and 5 years
Number of emergency room visits
Time frame: Change from baseline at 1, 2, 3, 4 and 5 years
Number of outpatient visits
Time frame: Change from baseline at 1, 2, 3, 4 and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 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.
10 sites 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 10 sites in Taiwan.
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 7 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change from baseline in total scores of the Hemophilia Joint Health Score (HJHS) for all joints (time frame: At 1, 2, 3, 4 and 5 years). The study lists 3 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 25 Sep 2026.