Phase 4: testing Efanesoctocog alfa for Factor VIII Deficiency
The objective of the study is to assess the improvement of synovial hypertrophy during the 12 months of efanesoctocog alfa prophylaxis once per week (QW) in joints with existing evidence of synovial hypertrophy in participants with hemophilia A. The study duration for each participant is approximately 12 months.
Official registry: https://clinicaltrials.gov/study/NCT06941870 · Sanofi · enrollment listed as 35
What this phase means
Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Efanesoctocog alfa. The registry lists allocation as randomized. The objective of the study is to assess the improvement of synovial hypertrophy during the 12 months of efanesoctocog alfa prophylaxis once per week (QW) in joints with existing evidence of synovial hypertrophy in participants with hemophilia A.
They plan to enroll about 35 people at 19 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Prospective Interventional Study of Effectiveness of Efanesoctocog Alfa Prophylaxis on Synovial Hypertrophy in Patients With Hemophilia A
Interventions: Efanesoctocog alfa
Primary outcome (registry wording): Proportion of joints with improvement in the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) synovitis domain score
Who it is for (from inclusion criteria)
- Ages 12 Years to any
- Participant is diagnosed with moderate to severe hemophilia A (defined as less than or equal to (≤)5 percent (%) of endogenous FVIII clotting activity) at the time of consent/assent
- Participant is more than or equal to (≥)12 years old at the time of consent/assent
- Participant has existing synovial hypertrophy, defined as at least 1 eligible\* joint by the HEAD-US score (Synovitis score: 1 or 2) at the time of consent/assent
- Participant has at least 1 eligible\* joint without planned future major orthopedic procedures (example, arthroscopic synovectomy, radioisotopic or chemical synoviorthesis), or major orthopedic procedures in the past 3 months prior to the screening visit (Visit 1)
- \*An eligible joint is a joint with existing synovial hypertrophy, as defined by a HEAD-US synovitis score of 1 or 2, considering hypertrophic synovium as an indication of the presence of synovitis
- Participant has received prophylactic treatment with hemophilia prophylaxis prescriptions in the last 12 months prior to the baseline visit (Visit 2)
- If male, no contraceptive measures are required for this study
Who the registry excludes
- Participants are excluded from the study if any of the following criteria apply:
- Has other associated clotting disorders at the time of consent/assent
- Is already under efanesoctocog alfa treatment
- Has a current diagnosis of an factor VIII (FVIII) inhibitor, defined as inhibitor titer ≥0.60 BU/mL
- Has ITI within the last 2 years prior to the baseline visit (Visit 2)
- Has been enrolled in a concurrent clinical treatment study or exposed to other investigational drug(s) within 3 months prior to screening for this study
- Is currently in an institution because of regulatory or legal order (that is, is a prisoner or a patient who is legally institutionalized)
Public study contact (from the registry)
Trial Transparency email recommended (Toll free for US & Canada)
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
19 listed- Orthopedic Institute for Children- Site Number : 8400009 — Los Angeles, California (completed)
- University of California Davis Medical Center-Site Number: 8400005 — Sacramento, California (recruiting)
- Indiana Hemophilia and Thrombosis Center- Site Number : 8400006 — Indianapolis, Indiana (recruiting)
- University of Iowa- Site Number : 8400004 — Iowa City, Iowa (recruiting)
- The Ohio State University Wexner Medical Center - CarePoint East- Site Number : 8400001 — Columbus, Ohio (completed)
- Oregon Health and Science University-Site Number: 8400002 — Portland, Oregon (recruiting)
- Washington Center for Bleeding Disorders- Site Number : 8400008 — Seattle, Washington (recruiting)
+ 12 sites outside the US on the same record
FAQ about this NCT record
Is NCT06941870 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06941870?
Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06941870?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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