INHIBIT Trials Platform: thresholds for maintaining type 1 error
| Study/hypothesis . | Posterior probability for superiority to stop at the interim, % . | Posterior probability to declare significance at the end of the study, % . |
|---|---|---|
| Prevention Trial/noninferiority hypothesis* | >99 | ≥95.7 |
| Prevention Trial/superiority hypothesis† | >99 | ≥95.1 |
| Eradication Trial/superiority hypothesis‡ | <0.005 or >99.5 | <2.3 or >97.7 |
| Study/hypothesis . | Posterior probability for superiority to stop at the interim, % . | Posterior probability to declare significance at the end of the study, % . |
|---|---|---|
| Prevention Trial/noninferiority hypothesis* | >99 | ≥95.7 |
| Prevention Trial/superiority hypothesis† | >99 | ≥95.1 |
| Eradication Trial/superiority hypothesis‡ | <0.005 or >99.5 | <2.3 or >97.7 |
The Prevention Trial noninferiority hypothesis is that emicizumab prophylaxis is noninferior to ELOCTATE prophylaxis in preventing inhibitor development in PUPs with severe hemophilia A over 48 weeks.
The Prevention Trial superiority hypothesis is that emicizumab prophylaxis is superior to ELOCTATE prophylaxis in preventing inhibitor development in PUPs with severe hemophilia A over 48 weeks.
The Eradication Trial superiority hypothesis is that ELOCTATE ITI plus emicizumab is superior to ELOCTATE ITI alone in eradicating inhibitor formation in PTPs with severe hemophilia A and inhibitors over 48 weeks.