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 looked at a clotting factor treatment called CSL627 in people with haemophilia A — a condition where the blood does not clot properly. The trial enrolled two groups: 222 people who had previously been treated for haemophilia (called "Previously Treated Patients" or PTPs), and 24 people who had never been treated before ("Previously Untreated Patients" or PUPs). Of those who started, 197 PTPs and 19 PUPs completed the study. The trial was mainly measuring whether participants developed "inhibitors" — antibodies that can block the treatment from working — as well as how often bleeding occurred and how well bleeding episodes were controlled. The reported data shows that among the previously treated patients, 0% developed inhibitors after 100 days of exposure to CSL627. For the previously untreated patients, 5 out of those who reached at least 50 days of exposure developed high-level inhibitors (defined as a level of 5 or more Bethesda units per millilitre, a standard laboratory measurement). For major bleeding episodes in PUPs, 100% were rated as successfully treated by the treating doctor. The reported annual rate of spontaneous (unprovoked) bleeds in PUPs was 1.9 for those on a regular preventive dosing schedule and 4.04 for those treated only when bleeding occurred. For previously treated patients, 87.1% of all bleeding episodes were rated as successfully treated. The reported annual overall bleeding rates were also recorded — for PTPs these were 28.32 (on-demand) and 2.84 (preventive dosing), and for PUPs 5.12 (on-demand) and 5.94 (preventive dosing). 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 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:
- Male patients of any age with severe hemophilia A (meaning their body produces less than 1% of the normal clotting factor) who took part in a previous related clinical study using this same treatment (rVIII-SingleChain).
- Male patients aged 0 to under 65 with severe hemophilia A who have already received at least 50 treatment sessions with any Factor VIII (clotting factor) product, and are not currently in another related study using this treatment.
- Male patients aged 0 to under 18 with severe hemophilia A who have never previously been treated with any Factor VIII product (except for short-term use of blood transfusion products).
- Patients in the above "never treated" group who have developed a specific immune reaction (called an inhibitor) to the study treatment during the main part of the trial may be eligible for an additional sub-study.
Who may not be able to join:
- Anyone with a known or suspected allergy to the study treatment or any of its ingredients, including proteins derived from Chinese hamster ovary cells (used in making the treatment).
- Anyone currently taking a medication that is not allowed during this study.
- Anyone whose kidney or liver test results are significantly above the normal range at the screening stage (confirm with trial site).
- Anyone who has a close family member (such as a brother or sibling) who has developed an immune reaction (inhibitor) against Factor VIII treatment.
- Patients who have previously used Factor VIII products (and are not joining directly from a previous related study) who have ever had, or currently have, an immune reaction (inhibitor) to Factor VIII treatment.
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: Program Director, CSL Behring
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
Incidence of Inhibitor Formation to FVIII in Previously Treated Patients (PTPs) With 100 Exposure Days (EDs) to CSL627; Number of Previously Untreated Patients (PUPs) With High-titer Inhibitor Formation to FVIII With at Least 50 EDs to CSL627; Percent Treatment Success for Major Bleeding Episodes in PUPs; Annualized Spontaneous Bleeding Rate in PUPs
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.