NCT06684314Active, not recruiting
A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A in Taiwan
PROphylactic Efanesoctocog Alfa Therapy Evaluated for Critical Joint Health in Hemophilia A Treatment: The PROTECT-ALT Study
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 79 (actual)
- First submitted
- 8 Nov 2024
- Start date
- 11 Nov 2024
- Primary completion date
- 28 Aug 2031
- Lead sponsor
- Sanofi
- Diseases
- Haemophilia
- NCT number
- NCT06684314
What you commit to
- Study type: Observational
- Participants enrolled: 79
- From 11 Nov 2024 to the primary completion date, 28 Aug 2031
- 10 sites 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.
Prior treatment
- Participants currently receive factor therapy and have signs of decreased response to FVIII therapy
- Enrollment in another concurrent clinical interventional study, or intake of an Investigational Medicinal Product within 3 months prior to inclusion in this study
Other illness
- Participants with coagulation disorders other than hemophilia A
- Participants diagnosed with other known bleeding disorder
Other
- Participants with a baseline Radiological Pettersson score (PS) of greater than 6 for each individual ankle
- Pregnant female participants
- The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Changhua | Taiwan | Unknown status |
| - Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| - Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| - Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Unknown status |
| - Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| - Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| - Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| - Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| - Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| - Coordinator of this site? Confirm its status | Taoyuan City | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.