Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

The proportion of subjects who have newly reported hepatitis B-related complications during AI463049 (reported by Phase III treatment groups)

Outcome Description:

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

Outcome Time Frame:

data is collected every 6 months

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

AI463-049

NCT ID:

NCT01337479

Start Date:

February 2003

Completion Date:

September 2010

Related Keywords:

• Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

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