Overview

This trial is active, not recruiting.

Condition chronic hepatitis b
Sponsor Bristol-Myers Squibb
Start date December 2012
End date April 2019
Trial size 3435 participants
Trial identifier NCT01726439, AI463-952

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
CHB patients who are naive to NUC at enrollment and be treated at hospitals at tier 2 cities in China

Primary Outcomes

Measure
Proportion of patients who achieve virology response (defined as HBV DNA < 300 copies/mL) by ETV monotherapy in comparison with LAM-based therapy
time frame: 48 weeks after initial NUC antiviral therapy

Secondary Outcomes

Measure
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
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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - CHB patients, or CHB patients with compensated cirrhosis, as defined by the current Chinese guidelines - Male or female - ≥ 18 years of age - Either Hepatitis B e antigen (HBeAg) positive or negative - Naïve to NUC (defined as no previous exposure to NUC treatment as based on patient self-report) - Has compensated liver disease - Patients with compensated cirrhosis - Patients who consent to participate in this study - Local residents with medical reimbursement coverage preferred Exclusion Criteria: - Co-infected with hepatitis C virus (HCV) - CHB patients with decompensated cirrhosis, liver failure, hepatocellular carcinoma, or any other types of malignancy at the screening phase - CHB patients who are being treated by interferon therapy within 6 months immediately prior to the screening phase of this study - CHB patients with a confirmed pregnancy

Additional Information

Official title A 5-year Prospective and Observational Study to Evaluate the Effectiveness of Nucleos(t)Ide Analogs (NUC) Therapy Among Chronic Hepatitis B (CHB) Patients Naive to NUC in Real World Practice at Hospitals in Tier 2 Cities in China (the EVOLVE Study)
Description Sampling Method: Consecutive patient sampling Biospecimen Retention: Blood samples for HBV viral load testing along the treatment period of this study
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Bristol-Myers Squibb.