Purpose of this Study
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Here is a summary for a 5th grade audience, without contractions, apostrophes, or bullet points:
This study is testing a medicine called denecimig for people who need help with blood clotting because their bodies do not have enough factor VIII. Denecimig is given as a shot under the skin and is designed to do the job of factor VIII in the blood.
Participants will receive the study medicine once a month for the first 12 weeks. After that, the study doctor may decide that the medicine should be given once a month, every two weeks, or every week. Participants will come to the clinic for regular visits where doctors will do blood tests and physical exams to check their health and see how well the treatment is working. The final study visit will take place about five months after the last dose of the study medicine.
Who Can Participate?
Eligibility
People can join this study if they are 18 years old or older and have been newly diagnosed with acquired hemophilia A, a condition that makes it harder for the blood to clot. They cannot join if they have had a blood clot in the past or if they are taking medicines that thin the blood or prevent blood cells called platelets from sticking together. Researchers are studying a new treatment to see if it is safe and helps control bleeding in people with this condition.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
The purpose of this study is to learn how safe denecimig is and how well it works for people with acquired hemophilia A.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A multinational, open-label study to investigate efficacy and safety of denecimig (Mim8) in adults with acquired haemophilia A
Principal Investigator
Ara
Metjian
Protocol Number
PRO00120750
NCT ID
NCT07830732
Phase
III
Enrollment Status
Pending Open to Enrollment