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
1Data from the Chang Gung Memorial Hospital, the major site of the study
Table 2: Meta-analysis of Ta1 CHB monotherapy studies.
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