Different doses of Inno8 for adults with haemophilia A.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, multicenter study will administer varying doses of the investigational drug Inno8 to adult males with congenital haemophilia A and monitor safety and drug levels over about 11 weeks. Participants will attend scheduled clinic visits for blood sampling, vital signs, and adverse event monitoring. Eligible participants are males aged 18–64 with factor VIII activity ≤15% who meet weight and other health criteria. The study is sponsored by Novo Nordisk and conducted at three US haemophilia centers.

Why it matters

Who can join: the full rules

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.

Where it's running

• UC Denver Hemoph & Thrombo Ctr
  Aurora, Colorado, United States Recruiting
• Indiana Hemophilia-Thromb Ctr
  Indianapolis, Indiana, United States Recruiting
• University of Iowa_Iowa City
  Iowa City, Iowa, United States Recruiting
• Penn State MS Hershey Med Ctr
  Hershey, Pennsylvania, United States Recruiting
• St Christopher Hosp for Child
  Philadelphia, Pennsylvania, United States Recruiting
• Universitätsklinik für Innere Medizin V
  Innsbruck, Austria Recruiting

Study contacts

• Study coordinator: Novo Nordisk
• Email: clinicaltrials@novonordisk.com
• Phone: (+1) 866-867-7178

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Denecimig (Mim8) for adults with acquired Haemophilia A

  This study tests whether denecimig can be safe and helpful for adults newly diagnosed with acquired Haemophilia A.

  Recruiting Phase 3 Novo Nordisk A/S · Iowa City, Iowa and 82 other locations · NCT07830732

• Surgical Use of Efanoctocog alfa in Hemophilia A Patients

  This observational study looks at how efanesoctocog alfa (Altuvoct) is used around surgery in people with hemophilia A to see if it helps control bleeding.

  Recruiting Hospices Civils de Lyon · Bron · NCT07723560

• SCT800 for preventing and treating bleeds in previously untreated severe hemophilia A patients

  This test tries SCT800, a recombinant factor VIII, as regular prevention and to treat bleeds in male patients with severe hemophilia A who haven't had prior factor VIII treatment.

  Recruiting Phase 3 Sinocelltech Ltd. · Beijing, Beijing Municipality · NCT07437404

• Evaluating synovitis in adults with haemophilia A

  This study looks at how often adults with hemophilia A experience joint inflammation caused by bleeding and how it affects their joint health.

  Recruiting University Hospital, Bonn · Bonn, North Rhine-Westphalia · NCT06352216

• Evaluating the effectiveness and safety of FVIII concentrates in young haemophilia A patients

  This study is testing how well and safely a new treatment for hemophilia A works in young children who haven't had much treatment before.

  Recruiting at 33 sites Octapharma · Miami, Florida and 58 other locations · NCT03695978

• Survey on the success of individualized treatment for haemophilia A

  This study is testing whether a personalized high-dose treatment can help people with haemophilia A who have developed inhibitors against factor VIII and if certain lab tests can predict how well this treatment will work.

  Recruiting Haemophilia Centre Rhine Main · Frankfurt am Main, Hesse · NCT02207894

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.