Baseline characteristics of patients treated with rFIX
| Characteristic . | No. (%) . |
|---|---|
| Sex, male | 56 (100) |
| Race | |
| White | 51 (91.1) |
| African American | 2 (3.5) |
| Asian | 1 (1.8) |
| Asian-white | 1 (1.8) |
| Hispanic | 1 (1.8) |
| Age, y | |
| Median | 23 |
| Range | 4-56 |
| Hemophilia severity, %* | |
| Below 1 | 46 (82.1) |
| From 1 to 3 | 9 (16.1) |
| Higher than 3 to 5 | 1 (1.8) |
| Previous exposure days | |
| From 20 to 100 | 8 (14.0) |
| More than 100 to 250 | 22 (39.2) |
| More than 250 | 26 (46.4) |
| HIV antibody status† | |
| Negative | 49 (87.5) |
| Positive‡ | 7 (12.5) |
| Hepatitis A antibody status† | |
| Negative | 32 (57.1) |
| Positive | 24 (42.9) |
| Hepatitis B antibody status† | |
| Negative | 5 (8.9) |
| Positive | 51 (91.1) |
| Hepatitis C antibody status† | |
| Negative | 13 (23.2) |
| Positive | 43 (76.8) |
| Factor IX antigen status | |
| Negative | 33 (59) |
| Positive | 22 (39) |
| Indeterminate1-153 | 1 (2) |
| Characteristic . | No. (%) . |
|---|---|
| Sex, male | 56 (100) |
| Race | |
| White | 51 (91.1) |
| African American | 2 (3.5) |
| Asian | 1 (1.8) |
| Asian-white | 1 (1.8) |
| Hispanic | 1 (1.8) |
| Age, y | |
| Median | 23 |
| Range | 4-56 |
| Hemophilia severity, %* | |
| Below 1 | 46 (82.1) |
| From 1 to 3 | 9 (16.1) |
| Higher than 3 to 5 | 1 (1.8) |
| Previous exposure days | |
| From 20 to 100 | 8 (14.0) |
| More than 100 to 250 | 22 (39.2) |
| More than 250 | 26 (46.4) |
| HIV antibody status† | |
| Negative | 49 (87.5) |
| Positive‡ | 7 (12.5) |
| Hepatitis A antibody status† | |
| Negative | 32 (57.1) |
| Positive | 24 (42.9) |
| Hepatitis B antibody status† | |
| Negative | 5 (8.9) |
| Positive | 51 (91.1) |
| Hepatitis C antibody status† | |
| Negative | 13 (23.2) |
| Positive | 43 (76.8) |
| Factor IX antigen status | |
| Negative | 33 (59) |
| Positive | 22 (39) |
| Indeterminate1-153 | 1 (2) |
N = 56.
Percent circulating FIX activity measured by the one-stage clotting assay before administration of the initial dose of rFIX in the baseline PK evaluation. Normal is 100% or 100 IU/dL.
Antibody status was determined at study entry.
All 7 HIV+ patients were positive for HAV, HBV, and HCV in some combination.
Assay interference precludes the assessment of factor IX antigen status.