Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Ha… (NCT06285071) | Clinical Trial Compass
By InvitationNot Applicable
Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors
Japan23 participantsStarted 2024-08-08
Plain-language summary
The purpose of the study is to investigate the safety and effectiveness of Alhemo® in all participants under real-world clinical practice in Japan. Participants will get Alhemo® as prescribed by the study doctor. The study will last for about 2 years.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
* The decision to initiate treatment with commercially available Alhemo® has been made by the patient/LAR and the treating physician before and independently from the decision to include the patient in this study
* Male or female patients, regardless of age
* Diagnosis with HAwI/HBwI
Exclusion Criteria:
\- Previous participation in this study. Participation is defined as having given informed consent in this study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a post-marketing surveillance study rather than a traditional clinical trial, what does that mean for my access to Alhemo® — would I be receiving it as part of my standard care or specifically because of this study?
2This study is tracking adverse reactions in real-world patients with haemophilia A or B who have inhibitors — given my specific inhibitor status and history, what side effects or safety signals should I be most aware of if Alhemo® is considered for me?
3Because this study is 'enrolling by invitation only,' how would I even be considered for participation, and who decides whether I qualify?
4Alhemo® is already approved and this study is collecting safety data on how it performs outside of controlled trials — does that mean there is more or less known about its risks compared to treatments I might already be on for my inhibitors?
5Are there standard treatments or other approved options for haemophilia with inhibitors that you would recommend I consider before or alongside discussing participation in this surveillance programme?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of adverse reaction (AR)
Timeframe: From baseline (week 0) to end of study (week 104)