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Clinical Trials in India / NCT07830732
Starting soon Phase 3

A Research Study Investigating Denecimig (Mim8) in Adults With Acquired Haemophilia A

NCT07830732 · tracked via the Priya Life Science India tracker
Sponsor
Novo Nordisk A/S
Phase
Phase 3
Started
2026-10-09
Last updated
2026-09-21

Condition(s) studied

Haemophilia A

Investigational drug(s) / intervention(s)

Denecimig

Denecimig: Participants will receive subcutaneous (s.c.) injections of denecimig.

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * Male or female participants (sex assigned at birth, inclusive of all gender identities) newly diagnosed with acquired haemophilia A (AHA) prior to signing the informed consent form, with AHA diagnosis (FVIII activity lesser than (\<) 50 percentage (%) and FVIII inhibitors greater than (\>) 0.6 Bethesda units \[BU\]) confirmed at screening. * Treatment-requiring bleed(s) due to AHA from diagnosis and until screening. * The participant is capable of following study procedures and able to seek medical attention when needed. Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate and highly effective contraceptive method. * Previous or current thromboembolic disease or eventsa (with the exception of previous catheter associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or risk of thromboembolic disease. * Life expectancy \<3 months at the time of screening, as evaluated by the investigator. * Therapy with immunosuppressive or immune modulating drugs for treatment of AHA (other than less than or equal to (≤) 2 days of prednisolone (or equivalent) for AHA at a dose ≤100 mg per day) prior to screening. * Immunosuppressive therapy (IST) initiated prior to AHA diagnosis for other medical conditions (e.g., other autoimmune disorders) is permitted, provided it was initiated greater than or equal to (≥) 6 months prior to screening, has been maintained at a stable dose and regimen since initiation, and is expected to remain at a stable dose and regimen at least during the main treatment period (Weeks 0-12).

Primary outcome measure(s)

Trial sites (83)

FacilityCityRegionStatus
University of Iowa_Iowa City Iowa City Iowa
Tulane University School of Medicine Metairie Louisiana
University of Minnesota Minneapolis Minnesota
Mayo Clinic Rochester Minnesota
Washington University St Louis Missouri
University of North Carolina Chapel Hill North Carolina
Duke University_Durham Durham North Carolina
University of Oklahoma Health Oklahoma City Oklahoma
Penn State MS Hershey Med Ctr Hershey Pennsylvania
Univ of Pennsylvania Hospital Philadelphia Pennsylvania
UT Southwestern Dallas Texas
Univ Texas HSC-Houston Houston Texas
UT Health San Antonio San Antonio Texas
University of Utah Health Salt Lake City Utah
University of Vermont Med Ctr Burlington Vermont
University of Virginia Charlottesville Virginia
Virginia Cwealth Univ Richmond Richmond Virginia
Washington Ctr Bleed Disorder Seattle Washington
Instituto de Hematologia DR.Ruben Davoli Rosario Santa Fe Province
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich Buenos Aires Argentina
Servicio de Hematologia - Hospital Italiano Buenos Aires Argentina
Royal Prince Alfred Hospital - Department of Haematology Camperdown New South Wales
Royal Brisbane and Women's Hospital - Integrated Cancer Research (I-CARE) Herston Queensland
The Alfred - Cancer Trials Melbourne Victoria
Hemocentro UNICAMP Distrito de Barão Geraldo - Campinas São Paulo
Unidade de Pesquisa Clínica do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo Ribeirão Preto São Paulo
Hospital das Clínicas da Faculdade de Medicina da USP São Paulo São Paulo
Hemorio-Fundarj Rio de Janeiro Brazil
Hospital Samaritano Higienópolis - Instituto de Conhecimento Ensino e Pesquisa (ICEP) São Paulo Brazil
St Pauls Hospital Vancouver British Columbia
McMaster University Hamilton Ontario
St. Michael's Hospital Toronto Ontario
Skejby Blodsygdomme, blødercentret Aarhus N Denmark
HCL - HOPITAL LOUIS PRADEL - Unité d'hémostase Clinique Bron France
HOPITAL DE BICETRE_Centre de l'Hémophilie Le Kremlin-Bicêtre France
INSTITUT COEUR POUMON_Service d'hémostase et transfusion Lille France
CHU DE NANTES-HOPITAL HOTEL-DIEU_Centre régional de traitement de l'Hémophilie Nantes France
Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain Berlin Germany
Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie Bonn Germany
Medizinische Hochschule Hannover - Hämatologie, Hämostaseologie, Onkologie Hanover Germany

+ 43 more sites — see the full list on the official registry below.

More Novo Nordisk A/S trials in India

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07830732 on ClinicalTrials.gov ↗ ← All trials in India