What is the
Honey-B study?

The goal of the Honey-B study is to enroll adolescent and adult men aged between 16 and 65 years old with moderately severe to severe hemophilia B. The study doctors will collect at least 6 months of information on how often each study participant experiences a bleed that requires additional treatment while continuing to take his usual FIX replacement therapy.


Participants in this study may be invited to also participate in a future clinical trial studying the safety of an investigational treatment.

What are the study treatments?

If you choose to participate in this study, you will not receive any study medication; you will only continue to take your usual FIX replacement therapy. Your doctor will collect information on how often you experience bleeding that requires additional treatment. There are no experimental treatments being tested in this study.

What can I expect if I participate?

Study participation is 100% voluntary (your choice). You will receive information on what to expect, as well as your role and responsibilities if you join the Honey-B study. You may leave the study at any time without it changing your regular health care.


If you join the study, there are certain things you will be expected to do. This includes attending study visits, getting your body weight, height, temperature, blood pressure and respiration rate taken by your study team, getting a scan of your liver to see if it’s healthy, telling your doctor when you experience bleeding that requires additional treatment and getting your blood drawn for some tests. Your participation may last a minimum of 6 months and up to 2 years with up to 9 study visits. If you are unable to go to your doctor for your study visits, they may be performed at your home.


Please note: the screening visit will be performed within 12 weeks of a pre-screening visit.

Figure 1: Study Flow Diagram

AT LEAST 6 MONTHS UP TO 24 MONTHS

SCREENING

  • Informed Consent
  • Inclusion/Exclusion

REMOTE/
DIGITAL
ASSESSMENTS

  • Bleeding Events
  • FIX Replacement Usage
  • Patient Reported Outcomes

CLINIC
ASSESSMENTS*

  • FIX activity
  • Biomarkers
  • Hemophilia Joint Health Score
  • Adverse Events and Concomitant Medications

*Where possible, certain clinic assessments may be performed remotely.

Qualified participants may also be compensated for certain travel and food costs that are related to study visits. The study team will discuss all of this with you.

How can I take part?

If you wish to take part in Honey-B, you can complete a questionnaire to see if you qualify.

What else should I know?

You will be given an Informed Consent Form (ICF) that will have more information on the study and what to expect if you participate. Even though you will not receive any study medication in this study, the ICF will give you more information on any possible risks and side effects you may experience when getting your blood drawn or getting a scan of your liver. Your health and safety are our top priorities and you will be closely monitored during your participation.


You are free to withdraw from the study for any reason and at any time.

Find a study site near you

To find out more about Honey-B, and whether it may be right for you, please contact your closest study site – they will be more than happy to help.

Find your nearest study site >>

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