Study Design |
Study County |
Subjects Enrolled |
Clinical Outcome (at end of follow up) |
Randomized, placebo-controlled double-blind[34] |
United States Phase 2 |
20 |
Ta1 Placebo |
83% 25% |
p<0.04 |
Multicenter, randomized, placebo-controlled double-blind[111] |
United States Phase 3 |
99 |
Ta1 Placebo |
24% 12% |
p<0.11 |
Multicenter, randomized, controlled[112] |
Italy Phase 3 |
33 |
Ta1 IFN-alpha2b Historical control |
41% 25% 7% |
p=0.025 |
Multicenter, randomized, controlled open-label[113] |
Taiwan Phase 3 |
158 |
Ta1 (6 mo Rx) Ta1 (12 mo Rx) Control |
36% 27% 25% |
|
981 |
Ta1 (6 mo Rx) Ta1 (12 mo Rx) Control |
41% 38% 9% |
p<0.004 (6 mo vs. Control) |
Meta-analysis [110] |
United States, Taiwan, Italy |
223 |
Ta1 (6 mo Rx) Control |
36% 19% |
p=0.04 |
Abbreviations: CHB = chronic hepatits B; IFN = interferon; Ta1 = thymosin alpha 1; vs. = versus