FVIII activity responses after hFVIII(V) administration
Dose and subject ID no. . | No. of FVIII values 1% or higher/no. of observations . | Study days . | FVIII activity, %* . | Infusions after hFVIII(V)† . |
|---|---|---|---|---|
| Dose 1 | ||||
| 02001 | 2/23 | 113, 315 | 1.0, 1.8 | Fewer |
| 05001 | 1/8 | 93 | 6.6 | Fewer |
| 05002 | 10/22 | 10-297 | 1.0-3.0 | No change |
| Dose 2 | ||||
| 03001 | 1/35 | 32 | 1.7 | More |
| 03002 | 14/38 | 19-159 | 1.0-1.3 | More |
| 05003 | 5/26 | 9-237 | 1.0-6.2 | Fewer |
| Dose 3 | ||||
| 02002 | 2/6 | 302, 342 | 19, 1.1 | More |
| 03003 | NA‡ | - | ||
| 05004 | 5/15 | 8-211 | 1.1-2.6 | Fewer |
| Dose 4 | ||||
| 01001 | 0/15 | - | - | Fewer |
| 05005 | 2/13 | 33, 44 | 1.0, 1.4 | More |
| 05006 | 4/11 | 40-317 | 1.1-4.4 | More |
| Dose 5 | ||||
| 05007 | 2/37 | 11, 56 | 1.4, 2.1 | No change |
Dose and subject ID no. . | No. of FVIII values 1% or higher/no. of observations . | Study days . | FVIII activity, %* . | Infusions after hFVIII(V)† . |
|---|---|---|---|---|
| Dose 1 | ||||
| 02001 | 2/23 | 113, 315 | 1.0, 1.8 | Fewer |
| 05001 | 1/8 | 93 | 6.6 | Fewer |
| 05002 | 10/22 | 10-297 | 1.0-3.0 | No change |
| Dose 2 | ||||
| 03001 | 1/35 | 32 | 1.7 | More |
| 03002 | 14/38 | 19-159 | 1.0-1.3 | More |
| 05003 | 5/26 | 9-237 | 1.0-6.2 | Fewer |
| Dose 3 | ||||
| 02002 | 2/6 | 302, 342 | 19, 1.1 | More |
| 03003 | NA‡ | - | ||
| 05004 | 5/15 | 8-211 | 1.1-2.6 | Fewer |
| Dose 4 | ||||
| 01001 | 0/15 | - | - | Fewer |
| 05005 | 2/13 | 33, 44 | 1.0, 1.4 | More |
| 05006 | 4/11 | 40-317 | 1.1-4.4 | More |
| Dose 5 | ||||
| 05007 | 2/37 | 11, 56 | 1.4, 2.1 | No change |
NA indicates not available.
Reproducibility in the central laboratory, performed repeatedly on plasma samples from severe hemophilia A subjects, was X = 0.40, SD = 0.008, and CV = 1.99%.
Comparison of number of treatments with factor VIII during the year prior to administration of hFVIII(V) with the number of treatments during the year after administration. Subject no. 05004 was receiving prophylaxis 3 times per week prior to entry on study.
Subject dropped out of the study for personal reasons and was noncompliant with FVIII assays and treatment records.