An observational study in Chronic Hepatitis B, sponsored by Gilead Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-02-03.
Sponsored by Gilead Sciences · Observational
To determine whether HBeAg-positive and HBeAg-negative patients with HBV DNA greater than or less than 5 log10 and 4 log10 copies/mL, respectively, and with normal or minimally elevated liver transaminases have histological evidence of active liver disease.
To determine whether HBeAg-positive and HBeAg-negative patients with HBV DNA greater than or less than 5 log10 and 4 log10 copies/mL, respectively, and with normal or minimally elevated liver transaminases have histological evidence of active liver disease.
1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.
This study's planned enrollment of 100 is below the median of 390 across 407 observational studies indexed under Hepatitis B.
Browse Hepatitis B studies →Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Patients must meet all of the following inclusion criteria to be included in this study:
Age greater than or equal to 18 years. Documented laboratory diagnosis of HBV infection (HBsAg positive) at least 6 months prior to inclusion in this study. Treatment naive, HBeAg-positive and HBeAg-negative patients. At least one liver biopsy specimen obtained in 2004 and/or 2005 (post diagnosis) that is available for evaluation by an independent pathologist. Gilead may allow enrollment of subjects with biopsies available from 2003. An adequate section of a biopsy for the purposes of this study should have at least 1 cm of the needle core of tissue on the slide. HBV DNA greater than or less than 5 log10 copies/mL for HBeAg-positive and greater than or less than 4 log10 copies/mL for HBeAg negative patients. A minimum of two normal or minimally elevated hepatic transminases (ALT) values that are at least 3 months apart during 2004 and/or 2005. Gilead may allow enrollment of subjects with values available from 2003. Minimally elevated ALT is defined as between lower limit of normal (LLN) and 1.2 times upper limit of normal (ULN) for HBeAg-positive and between lower limit of normal (LLN) and 1.5 times upper limit of normal (ULN) for HBeAg-negative patients. Child-Turcotte-Pugh score less than 7 and no evidence of ascites, variceal bleeding, or hepatic encephalopathy or impaired clotting function within 12 months prior to the Enrollment Visit.
Exclusion Criteria:Patients who meet any of the following criteria are excluded from the study:
History or evidence of HIV, hepatitic C, or hepatitis D. Other causes for liver disease other than hepatitis B, including but not limited to: hemochromatosis, Alpha-1 antitrypsin deficiency, Wilson's disease, Drug-related liver disease, Autoimmune hepatitis, Alcoholic liver disease, Obesity-induced liver disease (nonalcoholic seatohepatitis, NASH). History of, or current alcohol or substance abuse judged by the investigator to potentially interfere with laboratory or biopsy results.
This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.
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