Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Avigen
With
Stanford University
Children's Hospital of Philadelphia
The Hemophilia Center of Western Pennsylvania
University of Washington
The University of Texas Health Science Center, Houston
University of Campinas, Brazil
Christian Medical College, Vellore, India
Royal Prince Alfred Hospital, Sydney, Australia
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Males with severe hemophilia B with Factor IX activity level \< 1% of normal.
Life expectancy of \> 1 year.
Age \> 18 years old.
Ability to give informed consent.
Greater than twenty exposure days of treatment with Factor IX protein.
No history or presence of an inhibitor to Factor IX protein.
Subjects must be able to receive Factor IX protein on a home infusion protocol.
Subjects must have a normal protime (PT).
Hepatitis C infected subjects will be evaluated for liver fibrosis based on liver biopsy data graded on a scale of 0-4 (Poynard et. al., 1997). Subjects who are Hepatitis C antibody and RNA positive and have not had a liver biopsy within the last 36 months will be required to have one.
