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New weekly shot could help control bleeding in hemophilia a

NCT ID NCT04204408

Disease control Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new medicine called Mim8 for people with hemophilia A, a condition where blood doesn't clot properly. Mim8 is given as a shot under the skin to help prevent bleeding episodes. The trial included 275 healthy volunteers and people with hemophilia A, with or without inhibitors, and lasted up to 44 months. Results focused on safety and how well the drug works to control bleeding.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

275 people

The number who actually took part.

Started

Jan 2020

Finished

Oct 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Single ascending dose part 1: * Male, aged 18-45 years (both inclusive) at the time of signing informed consent * Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator Multiple ascending dose part 2: * Male, aged 12-64 years (both inclusive) at the time of signing informed consent (Germany and Japan have local requirements) * Diagnosis of congenital haemophilia A with FVIII activity below 1% based on medical records Exploratory biomarker cohort: * Male, aged equal to or above 12 years at the time of signing informed consent (Germany and Japan have local requirements) * Diagnosis of congenital haemophilia A with FVIII activity below 1% based on medical recordsv Exclusion Criteria: Part 1: * Factor VIII activity equal to or above 150% at screening * Increased risk of thrombosis, e.g. known history of personal or first degree relative(s) with unprovoked deep vein thrombosis * Any clinical signs or established diagnosis of venous or arterial thromboembolic disease Part 2: * Known congenital or acquired coagulation disorders other than haemophilia A * Increased risk of thrombosis as evaluated by the investigator. E.g. known history of personal or first degree relative(s) with unprovoked deep vein thrombosis with exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing * Any clinical signs or established diagnosis of venous or arterial thromboembolic disease with exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing * Advanced atherosclerotic disease (e.g. known history of ischemic heart disease, ischemic stroke) as evaluated by the investigator * Any autoimmune disease that may increase the risk of thrombosis * Receipt of emicizumab or drugs with similar modes of action within 5 half-lives before trial product administration * Ongoing or planned immune tolerance induction therapy Exploratory biomarker cohort: * Known congenital or acquired coagulation disorders other than haemophilia A * Increased risk of thrombosis as evaluated by the investigator. E.g. known history of personal or first degree relative(s) with unprovoked deep vein thrombosis with exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing * Any clinical signs or established diagnosis of venous or arterial thromboembolic disease with exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing * Advanced atherosclerotic disease (e.g. known history of ischemic heart disease, ischemic stroke) as evaluated by the investigator * Any autoimmune disease that may increase the risk of thrombosis * Ongoing or planned immune tolerance induction therapy

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Conditions

The condition(s) this trial relates to.

hemophilia A

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Haemophilia A with or without inhibitors Healthy volunteers

Contacts and locations

Locations

  • Arizona H&T Phoenix Child Hosp

    Phoenix, Arizona, 85016-7710, United States

  • Charité - Campus Charité Mitte - Charité Research Organisation GmbH

    Berlin, 10117, Germany

  • Charlotte Maxeke Johannesburg Academic Hospital

    Parktown, Johannesburg, Gauteng, 2193, South Africa

  • Children's Healthcare Atlanta

    Atlanta, Georgia, 30322, United States

  • Children's Hospital Los Angeles - Endocrinology

    Los Angeles, California, 90027, United States

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201, United States

  • Cincinnati Child's Hsp Med Ctr

    Cincinnati, Ohio, 45229, United States

  • Dayton Children Hemostati Ctr

    Dayton, Ohio, 45404, United States

  • Ege Üniversitesi Hastanesi- Hematoloji

    Izmir, 35100, Turkey (Türkiye)

  • Hacettepe Üniversitesi Hastanesi- Endokrinoloji

    Ankara, 06230, Turkey (Türkiye)

  • Hospital La Fe - Hemostasia y Trombosis

    Valencia, 46026, Spain

  • Hospital Regional Universitario de Málaga

    Málaga, 29010, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Instytut Hematologii i Transfuzjologii

    Warsaw, Masovian Voivodeship, 02-776, Poland

  • Istituto di Medicina Int. A. Bianchi Bonomi Univ. Milano

    Milan, MI, 20124, Italy

  • Michigan State University

    East Lansing, Michigan, 48823, United States

  • Nagoya University Hospital_Blood Transfusion

    Aichi, 466-8560, Japan

  • Nara Medical University Hospital_Pediatrics

    Nara, 634-8522, Japan

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Oxford Haemophilia Comprehensive Care Center

    Oxford, OX3 7LJ, United Kingdom

  • Penn State MS Hershey Med Ctr

    Hershey, Pennsylvania, 17033-2360, United States

  • Pietersburg Hospital

    Polokwane, Limpopo, 0699, South Africa

  • Policlinico Umberto I Sezione Ematologia

    Roma, 00161, Italy

  • Royal Free Haemophilia Comprehensive Care Centre

    London, NW3 2QG, United Kingdom

  • Rush University Med. Cntr

    Chicago, Illinois, 60612, United States

  • St. Jude Clinic Novant Health

    Charlotte, North Carolina, 28204, United States

  • Szpital Uniwersytecki, Oddzial Kliniczny Hematologii

    Krakow, 30-688, Poland

  • Tokyo Medical Univ. Hospital_Laboratory Medicine

    Tokyo, 160-0023, Japan

  • Trakya Üniversitesi Tıp Fakültesi Hastanesi- Kardiyoloji

    Edirne, 22030, Turkey (Türkiye)

  • UMHAT Tsaritsa Yoanna - ISUL EAD, Pediatric clinical hematology and oncology

    Sofia, 1527, Bulgaria

  • University Of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Iowa_Iowa City

    Iowa City, Iowa, 52242, United States

  • Universitätsklinik für Hämatologie

    Bern, 3010, Switzerland

  • Universitätsklinik für Innere Medizin V

    Innsbruck, 6020, Austria

  • Universitätsklinik für Innere Medizin V

    Innsbruck, A 6020, Austria

  • Universitätsspital Zürich - Klinik für Medizinische Onkologie und Hämatologie

    Zurich, 8091, Switzerland

  • Uniwersytecki Szpital Kliniczny W Poznaniu

    Poznan, Greater Poland Voivodeship, 60-569, Poland

  • Vanderbilt Hemostasis Thrombosis Clinic

    Nashville, Tennessee, 37232, United States

  • Versiti, CCBD

    Milwaukee, Wisconsin, 53226, United States

  • Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain

    Berlin, 10249, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.