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

July 13, 2020 updated by: Bristol-Myers Squibb

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)

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

Study Overview

Status

Completed

Conditions

Detailed Description

Sampling Method: Consecutive patient sampling

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

Study Type

Observational

Enrollment (Actual)

3434

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Local Institution
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • Local Institution
      • Chongqing, Chongqing, China, 710032
        • Local Institution
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Local Institution
      • Quanzhou, Fujian, China, 362002
        • Local Institution
      • Xiamen, Fujian, China, 1361009
        • Local Institution
    • Guangdong
      • Foshan, Guangdong, China, 528000
        • Local Institution
      • Shenzhen, Guangdong, China, 528000
        • Local Institution
    • Guangxi
      • Nanning, Guangxi, China, 530000
        • Local Institution
    • Guizhou
      • Guiyang, Guizhou, China, 550000
        • Local Institution
      • Guiyang, Guizhou, China, 55000
        • Local Institution
    • Hainan
      • Haikou, Hainan, China, 570100
        • Local Institution
    • Hebei
      • Baoding, Hebei, China, 071000
        • Local Institution
      • Shijiazhuang, Hebei, China, 050000
        • Local Institution
    • Heilongjiang
      • Daqing, Heilongjiang, China, 163461
        • Local Institution
      • Haerbin, Heilongjiang, China, 150086
        • Local Institution
    • Henan
      • Zhengzhou, Henan, China, 430000
        • Local Institution
      • Zhengzhou, Henan, China, 450000
        • Local Institution
    • Hubei
      • Shiyan, Hubei, China, 430000
        • Local Institution
      • Wuhan, Hubei, China, 430022
        • Local Institution
      • Wuhan, Hubei, China, 430032
        • Local Institution
    • Hunan
      • Changsha, Hunan, China, 410008
        • Local Institution
      • Changsha, Hunan, China, 410006
        • Local Institution
      • Changsha, Hunan, China, 410013
        • Local Institution
    • Inner Mongolia
      • Erdos, Inner Mongolia, China, 17000
        • Local Institution
    • Jiangsu
      • Changshu, Jiangsu, China, 215500
        • Local Institution
      • Changzhou, Jiangsu, China, 213001
        • Local Institution
      • Nanjing, Jiangsu, China, 210000
        • Local Institution
      • Suzhou, Jiangsu, China, 215000
        • Local Institution
    • Jiangxi
      • Nangchang, Jiangxi, China, 330006
        • Local Institution
    • Jilin
      • Changchun, Jilin, China, 130000
        • Local Institution
      • Yanji, Jilin, China, 133000
        • Local Institution
    • Liaoning
      • Dalian, Liaoning, China, 116001
        • Local Institution
      • Fushun, Liaoning, China, 113000
        • Local Instution
      • Shengyang, Liaoning, China
        • Local Institution
      • Shenyang, Liaoning, China, 110006
        • Local Institution
    • Ningxia
      • Yinchuan, Ningxia, China, 750000
        • Local Institution
    • Shandong
      • Jinan, Shandong, China, 250000
        • Local Institution
      • Qingdao, Shandong, China, 266000
        • Local Institution
      • Yantai, Shandong, China, 264001
        • Local Institution
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Local Institution
      • Taiyuan, Shanxi, China, 30000
        • Local Institution
      • Xi'an, Shanxi, China, 710032
        • Local Institution
      • Xi'an, Shanxi, China, 710061
        • Local Institution
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Local Institution
      • Chengdu, Sichuan, China, 610072
        • Local Institution
    • Tianjin
      • Tianjin, Tianjin, China, 300000
        • Local Institution
    • Xinjiang
      • Urumqi, Xinjiang, China, 830001
        • Local Institution
      • Wulumuqi, Xinjiang, China, 830001
        • Local Institution
      • Wulumuqi, Xinjiang, China, 830052
        • Local Institution
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Local Institution
      • Hangzhou, Zhejiang, China, 310006
        • Local Institution
      • Hangzhou, Zhejiang, China, 310023
        • Local Institution
      • Jinghua, Zhejiang, China, 300000
        • Local Institution
      • Ningbo, Zhejiang, China, 315010
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48 weeks after initial NUC antiviral therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
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
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
48 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

November 6, 2012

First Submitted That Met QC Criteria

November 14, 2012

First Posted (Estimate)

November 15, 2012

Study Record Updates

Last Update Posted (Actual)

July 15, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI463-952

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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