Effectiveness of Nucleos(t)Ide Analogs (NUC) Therapy Among Naive CHB Patients in China
EVOLVE
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)
1 other identifier
observational
3,434
1 country
54
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2012
Longer than P75 for all trials
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2012
CompletedFirst Posted
Study publicly available on registry
November 15, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedJuly 15, 2020
July 1, 2020
6.1 years
November 6, 2012
July 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
48 weeks after initial NUC antiviral therapy
Secondary Outcomes (6)
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)
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)
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
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
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
24 weeks, 48 weeks, 72 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks
- +1 more secondary outcomes
Study Arms (1)
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
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
Local Institution
Beijing, Beijing Municipality, 100050, China
Local Institution
Chongqing, Chongqing Municipality, 400038, China
Local Institution
Chongqing, Chongqing Municipality, 710032, China
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Fuzhou, Fujian, 350000, China
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Quanzhou, Fujian, 362002, China
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Xiamen, Fujian, 1361009, China
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Foshan, Guangdong, 528000, China
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Shenzhen, Guangdong, 528000, China
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Nanning, Guangxi, 530000, China
Local institution
Guiyang, Guizhou, 550000, China
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Guiyang, Guizhou, 55000, China
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Haikou, Hainan, 570100, China
Local Institution
Baoding, Hebei, 071000, China
Local Institution
Shijiazhuang, Hebei, 050000, China
Local Institution
Daqing, Heilongjiang, 163461, China
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Haerbin, Heilongjiang, 150086, China
Local Institution
Zhengzhou, Henan, 430000, China
Local Institution
Zhengzhou, Henan, 450000, China
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Shiyan, Hubei, 430000, China
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Wuhan, Hubei, 430022, China
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Wuhan, Hubei, 430032, China
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Changsha, Hunan, 410006, China
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Changsha, Hunan, 410008, China
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Changsha, Hunan, 410013, China
Local Institution
Ordos, Inner Mongolia, 17000, China
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Changshu, Jiangsu, 215500, China
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Changzhou, Jiangsu, 213001, China
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Nanjing, Jiangsu, 210000, China
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Suzhou, Jiangsu, 215000, China
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Nangchang, Jiangxi, 330006, China
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Changchun, Jilin, 130000, China
Local institution
Yanji, Jilin, 133000, China
Local Institution
Dalian, Liaoning, 116001, China
Local Instution
Fushun, Liaoning, 113000, China
Local Institution
Shengyang, Liaoning, China
Local Institution
Shenyang, Liaoning, 110006, China
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Yinchuan, Ningxia, 750000, China
Local Institution
Jinan, Shandong, 250000, China
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Qingdao, Shandong, 266000, China
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Yantai, Shandong, 264001, China
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Taiyuan, Shanxi, 030000, China
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Taiyuan, Shanxi, 30000, China
Local Institution
Xi’an, Shanxi, 710032, China
Local Institution
Xi’an, Shanxi, 710061, China
Local Institution
Chengdu, Sichuan, 610041, China
Local Institution
Chengdu, Sichuan, 610072, China
Local Institution
Tianjin, Tianjin Municipality, 300000, China
Local Institution
Ürümqi, Xinjiang, 830001, China
Local Institution
Ürümqi, Xinjiang, 830052, China
Local institution
Hangzhou, Zhejiang, 310000, China
Local Institution
Hangzhou, Zhejiang, 310006, China
Local Institution
Hangzhou, Zhejiang, 310023, China
Local Institution
Jinghua, Zhejiang, 300000, China
Local Institution
Ningbo, Zhejiang, 315010, China
Related Publications (2)
Jia J, Shang J, Tang H, Jiang J, Ning Q, Dou X, Zhang S, Zhang M, Han T, Tan D, Zhou X, Chen G, Sheng J, Su Z, Chen H, Dai E, Ye Y, Guo Y, Shen Y, Yuan J, Wei Z, Zhu S; EVOLVE Study Group. Long-term outcomes in Chinese patients with chronic hepatitis B receiving nucleoside/nucleotide analogue therapy in real-world clinical practice: 5-year results from the EVOLVE study. Antivir Ther. 2020;25(6):293-304. doi: 10.3851/IMP3372.
PMID: 33090970DERIVEDJia J, Tang H, Ning Q, Jiang J, Dou X, Zhang M, Zhang S, Shang J, Lu W, Ye Y, Wang X, Li M, Liu J, Bo Q, Tan W; EVOLVE Study Group. Real-world evidence for nucleoside/nucleotide analogues in a 5-year multicentre study of antiviral-naive chronic hepatitis B patients in China: 52-week results. Antivir Ther. 2018;23(3):201-209. doi: 10.3851/IMP3205.
PMID: 29116050DERIVED
Related Links
Biospecimen
Serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2012
First Posted
November 15, 2012
Study Start
December 1, 2012
Primary Completion
December 31, 2018
Study Completion
December 31, 2018
Last Updated
July 15, 2020
Record last verified: 2020-07