Long-Term Assessment of Treatment Outcomes With Entecavir and Lamivudine for Chronic Hepatitis B Infection in Patients Who Have Enrolled in Phase III Entecavir Trials
Observational Model: Only subjects who participated in Entecavir Phase III studies AI463022,
AI463023, AI463026, and AI463027.
Number of groups/cohorts: 1 (All subjects were observed in the same manner).
Observational Model: Case-Only, Time Perspective: Prospective
The proportion of subjects who have newly reported hepatitis B-related complications during AI463049 (reported by Phase III treatment groups)
defined as follows: Hepatic cirrhosis (Diagnosis requires biopsy or imaging study) Esophageal Varices (Grade 1 or higher on endoscopy or barium swallow) Bleeding esophageal varices Ascites (Present on physical exam or imaging study) Hepatic encephalopathy (≥ Stage 2) Hepatocellular carcinoma Spontaneous bacterial peritonitis Gastric varices Bleeding gastric varices Hepatorenal syndrome
data is collected every 6 months
United States: Food and Drug Administration