An observational study in Chronic Hepatitis B, sponsored by Bristol-Myers Squibb. Completed at 55 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-15.
Sponsored by Bristol-Myers Squibb · Observational
To compare the effectiveness, in a real world practice setting in tier 2 cities of China, of Entecavir (ETV) monotherapy and Lamivudine (LAM) based therapies (including LAM monotherapy, de novo LAM + Adefovir [ADV] combination, and early add-on of ADV) among chronic hepatitis B (CHB) patients who are naive to NUC at enrollment to this study
Sampling Method: Consecutive patient sampling
Biospecimen Retention: Blood samples for HBV viral load testing along the treatment period of this study
1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.
This study's enrollment of 3,434 is above the median of 390 across 407 observational studies indexed under Hepatitis B.
Browse Hepatitis B studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Hospitals in Chinese tier 2 cities. The definition of these hospitals is the following:
Exclusion Criteria:
CHB patients who are naive to NUC at enrollment and be treated at hospitals at tier 2 cities in China
Proportion of patients who achieve virology response (defined as HBV DNA < 300 copies/mL) by ETV monotherapy in comparison with LAM-based therapy
Virology response is defined as Hepatitis B virus (HBV) Deoxyribonucleic acid (DNA) \< 300 copies/mL by a highly sensitive assay such as Roche COBAS or Abbott Real Time Polymerase chain reaction (PCR) performed in a one central laboratory
Time frame: 48 weeks after initial NUC antiviral therapy
Mean HBV DNA reductions after 48 weeks of treatment from baseline for ETV and LAM-based therapy patients (stratifying by the 3 LAM-based subgroups)
Time frame: Baseline (Day 1) and 48 weeks
Proportion of patients who achieve virology response by ETV in comparison with LAM-based therapy after 24 weeks and 96 weeks of treatment (stratifying by the 3 LAM based subgroups)
Time frame: 24 weeks and 96 weeks
Proportion of patients who modify their initial treatment options to manage suboptimal response or resistance after 24 weeks, 48 weeks, and 96 weeks of treatment among all treatment options
Time frame: 24 weeks, 48 weeks and 96 weeks
Proportion of patients who achieve virology response among other treatment options, including ADV, LdT, and combinations of NUCs, after 24 weeks, 48 weeks, 72 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks of treatment
HBV DNA levels at week 24 will be analyzed at the laboratories of hospitals where the patients are treated while evaluation of HBV DNA levels after 48 and 96 weeks of treatment will be conducted at the central laboratory
Time frame: 24 weeks, 48 weeks, 72 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks
Cumulative incidence of patients who develop viral breakthrough and/or genotypic resistance
Time frame: 24 weeks, 48 weeks, 72 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks
Cumulative incidence of clinical outcome (eg, HCC, death, decompensated cirrhosis) in ETV arm versus LAM-based and other treatment arms
Time frame: 48 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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