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Could a daily pill replace needles for hemophilia a?

NCT ID NCT07220564

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 3 times

Summary

This study tests an experimental oral medicine called Inno8 in 30 adults with hemophilia A. The goal is to see if it is safe and how the body processes it. Participants will take multiple doses over about 11 weeks. If successful, Inno8 could offer a more convenient way to control bleeding without regular injections.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

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

18 to 64 years

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: * Male * Age 18-64 years (both inclusive) at the time of signing the informed consent. * Body weight greater than or equal to (≥) 45 kilograms (kgs). * Diagnosis of congenital haemophilia A with factor VIII (FVIII) activity less than or equal to (≤) 15 percentage (%) with or without FVIII inhibitors, based on medical records. Exclusion Criteria: * Current or prior exposure to any prophylactic treatment for haemophilia A within 5 half-lives of the medicinal product by the time of screening. * Body mass index ≥30.0 kilogram per square meter (kg/m\^2). * 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. * Any known coagulation disorders other than haemophilia A. * Ongoing or planned immune tolerance induction therapy. * Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    30 sites in 11 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • AKH - Klin. Abt. f. Haematologie u. Haemostaseologie

    RECRUITING

    Vienna, 1090, Austria

  • AOU Careggi Firenze

    RECRUITING

    Florence, 50134, Italy

  • Azienda Ospedaliera Universitaria Federico II di Napoli

    RECRUITING

    Naples, 80131, Italy

  • Cliniques universitaires Saint-Luc

    NOT_YET_RECRUITING

    Brussels, 1200, Belgium

  • HCL - HOPITAL LOUIS PRADEL - Unité d'hémostase Clinique

    ACTIVE_NOT_RECRUITING

    Bron, 69500, France

  • Hospital Clinico Universitario de Salamanca

    ACTIVE_NOT_RECRUITING

    Salamanca, 37007, Spain

  • Hospital La Fe_Hemostasia y Trombosis

    ACTIVE_NOT_RECRUITING

    Valencia, 46026, Spain

  • Hospital Regional Universitario de Málaga

    RECRUITING

    Málaga, 29010, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Indiana Hemophilia-Thromb Ctr

    RECRUITING

    Indianapolis, Indiana, 46260, United States

  • Instytut Hematologii i Transfuzjologii

    RECRUITING

    Warsaw, 02-776, Poland

  • KS Solna - Koagulationsmottagningen

    RECRUITING

    Solna, 171 64, Sweden

  • Medizinische Hochschule Hannover - Hämatologie, Hämostaseologie, Onkologie

    RECRUITING

    Hanover, 30625, Germany

  • Penn State MS Hershey Med Ctr

    RECRUITING

    Hershey, Pennsylvania, 17033-2360, United States

  • Queen Elizabeth Hospital, Birmingham - Haemophilia

    RECRUITING

    Birmingham, B15 2TH, United Kingdom

  • Royal Free Hospital - Haemophilia

    RECRUITING

    London, NW3 2QG, United Kingdom

  • Royal Hallamshire Hospital

    RECRUITING

    Sheffield, S10 2JF, United Kingdom

  • Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego Slaskiego Uniwersytetu Medycznego w Katowicach

    NOT_YET_RECRUITING

    Katowice, 40-032, Poland

  • Skåne US - Koagulationsmottagning

    RECRUITING

    Malmö, 214 28, Sweden

  • St Christopher Hosp for Child

    RECRUITING

    Philadelphia, Pennsylvania, 19134, United States

  • UC Denver Hemoph & Thrombo Ctr

    RECRUITING

    Aurora, Colorado, 80045, United States

  • ULS De Santo António, E.P.E. _H.Santo António_ Imunohemoterapia

    RECRUITING

    Porto, 4050-342, Portugal

  • ULS São João, E.P.E._H.São João_Imunohemoterapia

    RECRUITING

    Porto, 4200-319, Portugal

  • University of Iowa_Iowa City

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • Universitätsklinik für Innere Medizin V

    RECRUITING

    Innsbruck, 6020, Austria

  • Universitätsklinikum Bonn - Institut für Experimentelle Hämatologie

    NOT_YET_RECRUITING

    Bonn, 53127, Germany

  • Uniwersytecki Szpital Kliniczny W Poznaniu

    NOT_YET_RECRUITING

    Poznan, 60-569, Poland

  • Uniwersytecki Szpital Kliniczny nr 1 Klinika Hematoonkologii i Transplantacji Szpiku

    NOT_YET_RECRUITING

    Lublin, 20-081, Poland

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    RECRUITING

    Bialystok, 15-276, Poland

  • Uniwersyteckie Centrum Kliniczne

    RECRUITING

    Gdansk, 80-214, Poland

  • Vivantes Netzwerk für Gesundheit GmbH - Vivantes Klinikum im Friedrichshain

    RECRUITING

    Berlin, 10249, Germany

  • Zentrum für Labormedizin

    RECRUITING

    Sankt Gallen, 9008, Switzerland

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