Effectiveness of Nucleos(t)Ide Analogs (NUC) Therapy Among Naive CHB Patients in China
NCT ID: NCT01726439
Last Updated: 2020-07-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
3434 participants
OBSERVATIONAL
2012-12-31
2018-12-31
Brief Summary
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Detailed Description
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Biospecimen Retention: Blood samples for HBV viral load testing along the treatment period of this study
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Beijing, Beijing Municipality, China
Local Institution
Chongqing, Chongqing Municipality, China
Local Institution
Chongqing, Chongqing Municipality, China
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Fuzhou, Fujian, China
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Quanzhou, Fujian, China
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Xiamen, Fujian, China
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Foshan, Guangdong, China
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Shenzhen, Guangdong, China
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Nanning, Guangxi, China
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Guiyang, Guizhou, China
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Guiyang, Guizhou, China
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Haikou, Hainan, China
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Baoding, Hebei, China
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Shijiazhuang, Hebei, China
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Daqing, Heilongjiang, China
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Haerbin, Heilongjiang, China
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Zhengzhou, Henan, China
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Zhengzhou, Henan, China
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Shiyan, Hubei, China
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Wuhan, Hubei, China
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Wuhan, Hubei, China
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Changsha, Hunan, China
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Changsha, Hunan, China
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Changsha, Hunan, China
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Ordos, Inner Mongolia, China
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Changshu, Jiangsu, China
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Changzhou, Jiangsu, China
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Nanjing, Jiangsu, China
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Suzhou, Jiangsu, China
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Nangchang, Jiangxi, China
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Changchun, Jilin, China
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Yanji, Jilin, China
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Dalian, Liaoning, China
Local Instution
Fushun, Liaoning, China
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Shengyang, Liaoning, China
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Shenyang, Liaoning, China
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Yinchuan, Ningxia, China
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Jinan, Shandong, China
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Qingdao, Shandong, China
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Yantai, Shandong, China
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Taiyuan, Shanxi, China
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Taiyuan, Shanxi, China
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Xi’an, Shanxi, China
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Xi’an, Shanxi, China
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Chengdu, Sichuan, China
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Chengdu, Sichuan, China
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Tianjin, Tianjin Municipality, China
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Ürümqi, Xinjiang, China
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Ürümqi, Xinjiang, China
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Hangzhou, Zhejiang, China
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Hangzhou, Zhejiang, China
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Hangzhou, Zhejiang, China
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Jinghua, Zhejiang, China
Local Institution
Ningbo, Zhejiang, China
Countries
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References
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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.
Related Links
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Investigator Inquiry form
Other Identifiers
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AI463-952
Identifier Type: -
Identifier Source: org_study_id
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