- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01726439
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
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Beijing
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Beijing, Beijing, China, 100050
- Local Institution
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Chongqing
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Chongqing, Chongqing, China, 400038
- Local Institution
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Chongqing, Chongqing, China, 710032
- Local Institution
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Fujian
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Fuzhou, Fujian, China, 350000
- Local Institution
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Quanzhou, Fujian, China, 362002
- Local Institution
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Xiamen, Fujian, China, 1361009
- Local Institution
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Guangdong
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Foshan, Guangdong, China, 528000
- Local Institution
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Shenzhen, Guangdong, China, 528000
- Local Institution
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Guangxi
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Nanning, Guangxi, China, 530000
- Local Institution
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Guizhou
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Guiyang, Guizhou, China, 550000
- Local Institution
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Guiyang, Guizhou, China, 55000
- Local Institution
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Hainan
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Haikou, Hainan, China, 570100
- Local Institution
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Hebei
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Baoding, Hebei, China, 071000
- Local Institution
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Shijiazhuang, Hebei, China, 050000
- Local Institution
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Heilongjiang
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Daqing, Heilongjiang, China, 163461
- Local Institution
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Haerbin, Heilongjiang, China, 150086
- Local Institution
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Henan
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Zhengzhou, Henan, China, 430000
- Local Institution
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Zhengzhou, Henan, China, 450000
- Local Institution
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Hubei
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Shiyan, Hubei, China, 430000
- Local Institution
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Wuhan, Hubei, China, 430022
- Local Institution
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Wuhan, Hubei, China, 430032
- Local Institution
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Hunan
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Changsha, Hunan, China, 410008
- Local Institution
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Changsha, Hunan, China, 410006
- Local Institution
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Changsha, Hunan, China, 410013
- Local Institution
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Inner Mongolia
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Erdos, Inner Mongolia, China, 17000
- Local Institution
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Jiangsu
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Changshu, Jiangsu, China, 215500
- Local Institution
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Changzhou, Jiangsu, China, 213001
- Local Institution
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Nanjing, Jiangsu, China, 210000
- Local Institution
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Suzhou, Jiangsu, China, 215000
- Local Institution
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Jiangxi
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Nangchang, Jiangxi, China, 330006
- Local Institution
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Jilin
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Changchun, Jilin, China, 130000
- Local Institution
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Yanji, Jilin, China, 133000
- Local Institution
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Liaoning
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Dalian, Liaoning, China, 116001
- Local Institution
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Fushun, Liaoning, China, 113000
- Local Instution
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Shengyang, Liaoning, China
- Local Institution
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Shenyang, Liaoning, China, 110006
- Local Institution
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Ningxia
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Yinchuan, Ningxia, China, 750000
- Local Institution
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Shandong
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Jinan, Shandong, China, 250000
- Local Institution
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Qingdao, Shandong, China, 266000
- Local Institution
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Yantai, Shandong, China, 264001
- Local Institution
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Shanxi
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Taiyuan, Shanxi, China, 030000
- Local Institution
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Taiyuan, Shanxi, China, 30000
- Local Institution
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Xi'an, Shanxi, China, 710032
- Local Institution
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Xi'an, Shanxi, China, 710061
- Local Institution
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Sichuan
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Chengdu, Sichuan, China, 610041
- Local Institution
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Chengdu, Sichuan, China, 610072
- Local Institution
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Tianjin
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Tianjin, Tianjin, China, 300000
- Local Institution
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Xinjiang
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Urumqi, Xinjiang, China, 830001
- Local Institution
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Wulumuqi, Xinjiang, China, 830001
- Local Institution
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Wulumuqi, Xinjiang, China, 830052
- Local Institution
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Zhejiang
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Hangzhou, Zhejiang, China, 310000
- Local Institution
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Hangzhou, Zhejiang, China, 310006
- Local Institution
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Hangzhou, Zhejiang, China, 310023
- Local Institution
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Jinghua, Zhejiang, China, 300000
- Local Institution
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Ningbo, Zhejiang, China, 315010
- Local Institution
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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 |
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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
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48 weeks after initial NUC antiviral therapy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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Baseline (Day 1) and 48 weeks
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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
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24 weeks and 96 weeks
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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
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24 weeks, 48 weeks and 96 weeks
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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
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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
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24 weeks, 48 weeks, 72 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks
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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
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24 weeks, 48 weeks, 72 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks
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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
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48 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- 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.
- Jia 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.
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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