NovoNordisk AHA

Purpose of this Study

Copilot said: 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