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 (NCT02847637) enrolled 152 people in total across four groups. Eighteen participants received no preventive treatment at first before later switching to emicizumab (the control group, Arm C); 36 received emicizumab at 1.5 mg/kg once a week (Arm A); 35 received emicizumab at 3 mg/kg every two weeks (Arm B); and 63 who had previously been on a standard clotting-factor treatment received emicizumab at 1.5 mg/kg once a week (Arm D). The trial was measuring how often participants experienced bleeds — specifically tracking bleeds that needed treatment, bleeds in joints, bleeds that happened without an obvious cause (spontaneous), and bleeds in joints that had been repeatedly affected before the trial started. The vast majority of participants completed the study. The reported data shows that the main outcome — the estimated number of treated bleeds per year — differed notably across groups. The control group (no preventive treatment) recorded an estimated 38.2 treated bleeds per year, while the three emicizumab groups recorded 1.5, 1.3, and 1.6 treated bleeds per year respectively. When all bleeds (treated and untreated) were counted, the control group recorded an estimated 47.6 per year, compared with 2.5, 2.6, and 3.3 per year in the emicizumab groups. For bleeds specifically in joints, the control group recorded an estimated 26.5 treated joint bleeds per year, versus 1.1, 0.9, and 1.2 in the emicizumab groups. For spontaneous treated bleeds, the figures were 15.6 per year in the control group and 1.0, 0.3, and 0.5 in the emicizumab groups. For bleeds in repeatedly affected ("target") joints, the control group recorded 13.0 per year versus 0.6, 0.7, and 0.6 in the emicizumab groups. A separate within-person comparison for participants who had previously been on standard clotting-factor treatment showed an estimated 4.8 treated bleeds per year before the study, compared with 1.5 per year while on emicizumab during the study. 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 ↗ · Read the linked publication on PubMed (PMID 35939785) ↗
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 3 Haemophilia Trial, Completed
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 weigh at least 40 kilograms (about 88 pounds) at the time of screening
- You have been diagnosed with severe congenital (present from birth) hemophilia A
- You have clear records of your hemophilia treatment and bleeding episodes from at least the past 24 weeks
- Your blood cell counts are at an acceptable level (confirm with trial site)
- Your liver is functioning adequately (confirm with trial site)
- Your kidneys are functioning adequately (confirm with trial site)
- If you are a woman who could become pregnant, you agree to either avoid sexual intercourse or use highly effective birth control during the study and for at least 24 weeks after your last dose
Who may not be able to join:
- You have a bleeding disorder other than hemophilia A, whether inherited or developed over time
- You have been treated for blood clots in the past or currently, or show signs of blood clotting problems
- You have any condition that may increase your risk of bleeding or blood clots
- You have previously had a significant allergic reaction to a monoclonal antibody therapy or to any ingredient in the study drug injection
- You have HIV with a CD4 cell count below 200 (a measure of immune system health) within the past 24 weeks — note that people with HIV whose CD4 count is above 200 and who meet all other criteria may still be eligible
- You are currently taking or plan to take immune-modifying medications during the study, except for HIV antiviral treatments
- You are considered at high risk for a serious condition affecting small blood vessels and blood cells, called thrombotic microangiopathy, based on your personal or family medical history
- You have another illness, treatment, or abnormal lab result that the study doctor believes could interfere with the study or put you at extra risk
- You have a major surgery planned during the study period
- You have previously received the study drug (emicizumab) in another study, or have recently taken another experimental drug related to hemophilia or otherwise (confirm exact timeframes with trial site)
- You are currently pregnant, breastfeeding, or planning to become pregnant during the study
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
Principal Investigator: Clinical Trials, Hoffmann-La Roche
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
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Annualized Bleeding Rate (ABR) for Treated Bleeds
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.