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New treatment option for Factor VIII Deficiency
Official title Efanesoctocog Alfa Prophylaxis in Patients With Hemophilia A With Synovial Hypertrophy
ClinicalTrials.gov ID: NCT06941870
What this study is testing
What is Efanesoctocog alfa?
Efanesoctocog alfa is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for factor viii deficiency.
Also referred to as BIVV001, ALTUVIIIO®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- Participant is diagnosed with moderate to severe hemophilia A (defined as less than or equal to (≤)5 percent (%) of endogenous FVIII clotting...
- 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...
- Participant has at least 1 eligible\ joint without planned future major orthopedic procedures (example, arthroscopic synovectomy, radioisotopic or...
- \ An eligible joint is a joint with existing synovial hypertrophy, as defined by a HEAD-US synovitis score of 1 or 2, considering hypertrophic...
You likely can't join if
- 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...
- 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...
- 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...
- Is an employee or family member of the investigator or site personnel. Is involved in a specific situation during study implementation or the course...
See the full eligibility criteria
- 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...
- \ 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...
- 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...
- A WOCBP must have a negative serum pregnancy test at the screening visit (Visit 1)
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- Columbus, Ohio, United States
- Hamilton, Ontario, Canada
- Kawasaki, Kanagawa, Japan
- Hiroshima, Japan
- Saitama, Japan
- Tokyo, Japan
- Kaohsiung City, Taiwan
- Taichung, Taiwan
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Indianapolis, Indiana, United States; Iowa City, Iowa, United States; Columbus, Ohio, United States; Hamilton, Ontario, Canada; Kawasaki, Kanagawa, Japan and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.