Phase 3 study for people with Haemophilia

Not yet recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Not yet recruiting
Phase Phase 3
Sponsor Novo Nordisk A/S
Registry number NCT07830732
Started 9 October 2026 Today 16 October 2026 Estimated completion 23 March 2029

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Royal Prince Alfred Hospital - Department of Haematology Camperdown NSW Status not stated
Royal Brisbane and Women's Hospital - Integrated Cancer Research (I-CARE) Herston QLD Status not stated
The Alfred - Cancer Trials Melbourne VIC Status not stated

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 84

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

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).

Dates on the record

Started 9 October 2026
Estimated completion 23 March 2029
Registry last updated 21 September 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 21 September 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.