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Denecimig for Hemophilia

(FRONTIERAHA Trial)

Not yet recruiting at 82 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Novo Nordisk A/S
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to find out if denecimig is safe and effective for treating people who have acquired haemophilia A. Participants will be in this study for up to around 1 year and 5 months (73 week).

Who Is on the Research Team?

CT

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

This trial is for adults who have developed acquired haemophilia A, a rare bleeding disorder. People with other types of hemophilia or certain health conditions may not be able to join.

Inclusion Criteria

Informed consent obtained before any study-related activities, including procedures to determine suitability for the study
I have been newly diagnosed with acquired haemophilia A and meet the required lab criteria.
I have had bleeding that needed treatment since my AHA diagnosis.
See 1 more

Exclusion Criteria

Life expectancy less than 3 months at screening as evaluated by investigator
I am pregnant, breastfeeding, or not using effective birth control.
I have a history or risk of blood clots, except treated catheter-related clots.
See 2 more

What Are the Treatments Tested in This Trial?

Interventions

  • Denecimig

Trial Overview

The study is testing a new medication called Denecimig (Mim8) to see if it is safe and works well in treating acquired haemophilia A. Participants will receive the treatment and be followed for about 1 year and 5 months.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: DenecimigExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials
1,578
Recruited
3,813,000+
Lars Fruergaard Jørgensen profile image

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange profile image

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

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