Potential subjects were excluded for a platelet count <50,000/mm3

Potential subjects were excluded for a platelet count <50,000/mm3, absolute neutrophil count <1,000/mm3, hematocrit level <33%, alpha-fetoprotein level >200 ng/mL, Child-Turcotte-Pugh (CTP) score ≥7, or a history of decompensated liver disease or hepatocellular carcinoma (HCC). Patients with other

causes of liver disease, uncontrolled comorbid medical (including malignancies, autoimmune disorders, and immunocompromised states) or psychiatric illnesses, or contraindications to interferon were excluded, as were pregnant or breast-feeding women. Potential participants in the HALT-C Trial were treated in a lead-in phase with peginterferon alfa-2a selleck chemical (180 μg/week subcutaneously) and ribavirin (1,000-1,200 mg/day);13 those who failed to clear hepatitis C virus

(HCV) RNA by week 20, categorized as nonresponders,11, ICG-001 12 were randomized to 3.5 years of 90 μg/week of peginterferon alfa-2a or to an untreated control group. Subjects with undetectable HCV RNA at treatment week 20 were categorized as responders and received combination treatment for 48 weeks. Responders with detectable HCV RNA after week 20 (breakthrough or relapsers) were also eligible for randomization. In addition, patients failing to achieve a sustained virologic response following see more peginterferon and ribavirin treatment administered outside the HALT-C Trial were also eligible for randomization. Of 1,730 screened subjects, 1,050 were randomized.12 Study subjects were seen in one of 10 clinical centers at 3-month intervals through month 48 and every 6 months thereafter until October 2009. Protocol-defined clinical outcomes included a CTP score of ≥7 on two consecutive study visits 3 months apart (6 months apart in the postrandomization phase), variceal hemorrhage, ascites, hepatic encephalopathy, spontaneous bacterial

peritonitis, definite HCC, or death either related or unrelated to liver disease. For this analysis we also included liver transplantation and presumed HCC as clinical outcomes. In addition to individual clinical outcomes, we defined three groups of clinical outcome. “Any clinical outcome” was the definition used in the original HALT-C Trial protocol and included death from any cause, presumed or definite HCC, variceal hemorrhage, ascites, spontaneous bacterial peritonitis or hepatic encephalopathy. “Decompensated liver disease” was defined as variceal hemorrhage, ascites, spontaneous bacterial peritonitis, or hepatic encephalopathy. “HCC/Decompensation” was defined as presumed or definite HCC, as defined,14 or decompensated liver disease.

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