Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT03597022) tested three different doses of an investigational drug called BAY1093884 — 100 mg, 225 mg, and 400 mg. A total of 24 people took part, with 8 in each dose group. Notably, none of the participants completed the study — all 24 did not finish, though the reasons for this are not detailed in the reported data. The trial was primarily measuring safety-related events, specifically looking at unwanted medical occurrences (called adverse events) that happened during or shortly after treatment. The reported data shows that when it came to unwanted medical events that investigators considered possibly linked to the study drug, 1 out of 8 participants in the 100 mg group, 4 out of 8 in the 225 mg group, and 5 out of 8 in the 400 mg group experienced such events. For more serious adverse events — those involving hospitalisation, life-threatening situations, or significant disability — the reported numbers were 1, 2, and 1 participants across the three dose groups respectively. Of those serious events, the investigators considered 0, 2, and 1 to be possibly related to the study drug. The trial also tracked specific events of concern such as blood clotting or allergic reactions: 0 participants in the 100 mg group, 2 in the 225 mg group, and 1 in the 400 mg group experienced these. No participants in any group were reported to have clinically significant abnormal laboratory test results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Haemophilia Trial, Terminated
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are a male with severe hemophilia A (with very low Factor VIII activity) or severe hemophilia B (with very low Factor IX activity), with or without inhibitors (antibodies that block clotting factors)
- You have had inhibitors in the past (at any level), even if you no longer have them
- You are 18 years old or older
- You have had at least 4 bleeding episodes of any kind in the 6 months before the screening visit (whether treated or not)
- If you are currently on a regular preventive treatment (prophylaxis), you are willing to pause it during the trial
- If you are currently on immune tolerance induction therapy (a treatment to reduce inhibitors), you are willing to pause it during the trial
Who may not be able to join:
- You have another blood clotting disorder or platelet disorder (such as a condition where clotting happens abnormally throughout the body, or a combined clotting factor deficiency)
- You have a history of serious blood clot conditions, such as a blood clot in the lungs, a deep vein clot in the leg, or a condition that damages small blood vessels
- You have risk factors for blood vessel problems, such as uncontrolled high blood pressure or uncontrolled diabetes
- You have a history of heart disease, coronary artery disease, or blocked arteries in other parts of the body
- Your platelet count (a measure of certain blood cells that help with clotting) is below a certain level (confirm with trial site)
- You have HIV with a weakened immune system, specifically a CD4 cell count below 200 (a measure of immune health) (confirm with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of Participants With Drug-related Treatment-emergent Adverse Events; Number of Participants With Serious Treatment-emergent Adverse Events; Number of Participants With Treatment-emergent Adverse Events of Special Interest; Number of Participants With Clinically Relevant Abnormalities in Laboratory Values
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.