Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
CSL Behring
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
1. Male
2. Age ≥18 years
3. Subjects with congenital hemophilia B, classified as severe or moderately severe, and are currently on factor IX prophylaxis
4. \>150 previous exposure days of treatment with factor IX protein
You may not be if
1. History of factor IX inhibitors
2. Positive factor IX inhibitor test at screening
3. Select screening laboratory value \>2 times upper limit of normal
4. Positive human immunodeficiency virus (HIV) test at screening, not controlled with anti-viral therapy
5. Active infection with hepatitis B or C virus at screening
6. History of Hepatitis B or C exposure, currently controlled by antiviral therapy at the end of the lead-in phase
7. Previous gene therapy treatment
8. Receipt of an experimental agent within 60 days prior to screening
9. Current participation or anticipated participation within one year after study drug administration in this trial in any other interventional clinical trial involving drugs or devices
Clareo Health | HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B Patients
