Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Effectiveness of Nucleos(t)Ide Analogs (NUC) Therapy Among Naive CHB Patients in China (EVOLVE)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Bristol-Myers Squibb Identifier:
First received: November 6, 2012
Last updated: April 10, 2017
Last verified: December 2016
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

Chronic Hepatitis B

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]
    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

Secondary Outcome Measures:
  • 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 ]
    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

  • 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 ]

Biospecimen Retention:   Samples With DNA

Estimated Enrollment: 3435
Study Start Date: December 2012
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
CHB patients who are naive to NUC treatment
CHB patients who are naive to NUC at enrollment and be treated at hospitals at tier 2 cities in China

Detailed Description:

Sampling Method: Consecutive patient sampling

Biospecimen Retention: Blood samples for HBV viral load testing along the treatment period of this study


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospitals in Chinese tier 2 cities. The definition of these hospitals is the following:

  • Hospitals where 300 or more CHB patients are treated monthly
  • Hospitals where PCR can be performed in the hospital's laboratory to measure HBV DNA serum levels

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01726439

  Show 55 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb Identifier: NCT01726439     History of Changes
Other Study ID Numbers: AI463-952
Study First Received: November 6, 2012
Last Updated: April 10, 2017

Additional relevant MeSH terms:
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human processed this record on May 24, 2017