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New treatment option for Hemophilia A With Inhibitor
Official title SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors
ClinicalTrials.gov ID: NCT04647227
What this study is testing
What is coagulation factor VIIa [recombinant]-jncw?
coagulation factor VIIa [recombinant]-jncw is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hemophilia a with inhibitor.
Also referred to as SEVENFACT.
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
- Phase IV multi-center, US-centric, open-label, safety study enrolling participants with Hemophilia A or B with inhibitors, 12 years of age and older, who are either on long term prophylactic treatment (e.g., emicizumab) at risk of experiencing a breakthrough bleeding event (BE), or who are not on prophylactic treatment who may need to control a BE.
- 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 to 100
You may be able to join if
- Have a diagnosis of hemophilia A or B with inhibitors.
- Be 12 years of age and older
- Be capable of understanding and willing to comply with the conditions of the protocol or have a legal guardian who is capable of understanding and...
- Have read, understood, and documented written informed consent/assent
- Be able to provide medical evidence through prior medical history of previous inhibitor levels
You likely can't join if
- Have a disorder of hemostasis in addition to Hemophilia A or B
- Have a known or suspected intolerance or hypersensitivity to SEVENFACT® or its ingredients
- Have a known allergy or hypersensitivity to rabbits or rabbit proteins
- Are receiving prophylactic treatment for bleeding with a drug or biologic that is not approved for this use by the FDA
- Have had implantation of an investigational medical device within the prior 6 months
- Have received an investigational drug within 30 days of the baseline visit
See the full eligibility criteria
- Have a diagnosis of hemophilia A or B with inhibitors.
- Be 12 years of age and older
- Be capable of understanding and willing to comply with the conditions of the protocol or have a legal guardian who is capable of understanding and complying with the conditions of the protocol
- Have read, understood, and documented written informed consent/assent
- Be able to provide medical evidence through prior medical history of previous inhibitor levels
- Be willing and able to use the ATHN mobile application or a paper diary to document BEs and medication usage
- Have a disorder of hemostasis in addition to Hemophilia A or B
- Have a known or suspected intolerance or hypersensitivity to SEVENFACT® or its ingredients
- Have a known allergy or hypersensitivity to rabbits or rabbit proteins
- Are receiving prophylactic treatment for bleeding with a drug or biologic that is not approved for this use by the FDA
- Have had implantation of an investigational medical device within the prior 6 months
- Have received an investigational drug within 30 days of the baseline visit
- Have an elective surgical procedure planned during the duration of their participation in the study\
- Have any life-threatening disease, or other disease or condition which, in the investigator's judgment, could pose a potential hazard to the patient or interfere with study participation or study outcome (e.g., a...
- Should a participant require an unplanned surgery, the participant will not be withdrawn from the study unless the investigator deems it necessary. Instead, the participant will receive standard of care treatment as...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- Washington D.C., District of Columbia, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Savannah, Georgia, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Lansing, Michigan, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- Kansas City, Missouri, United States
- New Hyde Park, New York, United States
- Greenville, North Carolina, United States
- Cleveland, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
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 to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Los Angeles, California, United States; Sacramento, California, United States; Washington D.C., District of Columbia, United States; Orlando, Florida, United States and 14 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.