Efanesoctocog Alfa Prophylaxis in Patients With Hemophilia A With Synovial Hypertrophy
NCT ID: NCT06941870
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
35 participants
INTERVENTIONAL
2025-09-23
2027-10-25
Brief Summary
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The study duration for each participant is approximately 12 months.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Efanesoctocog Alfa
Participants will receive Efanesoctocog Alfa at 50 international unit per kilogram (IU/kg) intravenous (IV) QW
Efanesoctocog alfa
Pharmaceutical form:Lyophilized powder in a sterile vial that requires reconstitution with sterile water for injection (diluent)-Route of administration:Intravenous
Interventions
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Efanesoctocog alfa
Pharmaceutical form:Lyophilized powder in a sterile vial that requires reconstitution with sterile water for injection (diluent)-Route of administration:Intravenous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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).
Participant is capable of understanding the written Informed Consent Form (ICF)/assent form, provides a signed and witnessed written ICF/assent form, and agrees to comply with the protocol requirements.
If male, no contraceptive measures are required for this study.
If female, is not pregnant or breastfeeding, and one of the following conditions applies:
Is a women of nonchildbearing potential (WONCBP) Is a women of childbearing potential (WOCBP) and agrees to use a highly effective contraceptive method, with a failure rate of less than (\<)1 percent during the study treatment period (at least until the Week 52/ End of Treatment \[EoT\] visit).
Exclusion Criteria
Has ITI within the last 2 years prior to the baseline visit (Visit 2). Has been enrolled in a concurrent clinical interventional 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).
Is not suitable for participation, whatever the reason, as judged by the investigator, including medical or clinical conditions, or patients potentially at risk of noncompliance to study procedures.
Is an employee or family member of the investigator or site personnel. Is involved in a specific situation during study implementation or the course of the study that may raise ethics considerations.
Has hypersensitivity to efanesoctocog alfa or its components or any of its excipients that, in the opinion of the investigator, contraindicates participation in the study.
12 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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Orthopedic Institute for Children- Site Number : 8400009
Los Angeles, California, United States
Innovative Hematology, Inc.- Site Number : 8400006
Indianapolis, Indiana, United States
University of Iowa- Site Number : 8400004
Iowa City, Iowa, United States
Ohio State University Hospital East- Site Number : 8400001
Columbus, Ohio, United States
Investigational Site Number : 1240003
Hamilton, Ontario, Canada
Investigational Site Number : 1240004
Hamilton, Ontario, Canada
Investigational Site Number : 3920003
Kawasaki, Kanagawa, Japan
Investigational Site Number : 3920002
Hiroshima, , Japan
Investigational Site Number : 3920001
Saitama, , Japan
Investigational Site Number : 3920004
Tokyo, , Japan
Investigational Site Number : 1580003
Kaohsiung City, , Taiwan
Investigational Site Number : 1580001
Taichung, , Taiwan
Investigational Site Number : 1580002
Taipei, , Taiwan
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Related Links
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LPS18168 Plain Language Results Summary
Other Identifiers
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U1111-1311-1701
Identifier Type: REGISTRY
Identifier Source: secondary_id
LPS18168
Identifier Type: -
Identifier Source: org_study_id
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