A prospective trial of @entity3812 for XXXX .

@entity1 @entity2835 @entity82 @entity66 @entity648 @entity409 @entity294 @entity1442 @entity3812 @entity99 @entity165
We entered 60 @entity1 with @entity2835 in a double-blind randomized controlled trial to determine whether @entity3812 is therapeutically effective. Thirty @entity1 had @entity66 (Stages 1 and 2), and 30 had @entity1442 (Stages 3 and 4). Fifteen @entity1 with @entity66 and 15 with @entity1442 received @entity3812 (0.6 mg twice daily), and the remainder received placebo. @entity1 were studied about every two months; those remaining in the blind phase at two years underwent repeat liver biopsy and were then placed on open-label @entity3812 (0.6 mg twice daily). With a few exceptions, the results in @entity1 with @entity66 were similar to those in @entity1 with @entity1442 ; hence, data on @entity1 in all stages were combined in the main analysis. During the two-year study period the @entity3812 -treated @entity1 , as compared with the placebo-treated @entity1 , had improvement in levels of serum albumin, serum @entity648 , alkaline phosphatase, @entity165 , and aminotransferases. However, there was no such improvement in the severity of symptoms or physical findings; moreover, there was no significant difference in the histologic changes noted at liver biopsy in the two treatment groups. At four years after entry, the cumulative mortality from @entity409 was 21 percent in @entity1 given @entity3812 and 47 percent in those given placebo (P = 0.05). The only side effect of @entity3812 was @entity294 , noted in three @entity1 . The consistent and significant improvement in a number of markers of @entity409 and the apparent decreased mortality from @entity409 suggest that @entity3812 may provide some long-term clinical benefit in @entity1 with @entity2835 . However, the failure of @entity3812 to reduce @entity99 and @entity82 leaves uncertain the effect of the drug on the longterm outcome of this disease.
