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

This study is currently recruiting participants.
Verified November 2013 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01726439
First received: November 6, 2012
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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


Condition
Chronic Hepatitis B

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A 2-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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Proportion of patients who achieve virology response by ETV in comparison with LAM-based therapy after 24 and 96 weeks of treatment (stratifying by the 3 LAM based subgroups) [ Time Frame: 24 weeks and 96 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients who modify their initial treatment options to manage suboptimal response or resistance after 24, 48, and 96 weeks of treatment among all treatment options [ Time Frame: 24 weeks, 48 weeks and 96 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients who achieve virology response among other treatment options, including ADV, LdT, and combinations of NUCs, after 24, 48 and 96 weeks of treatment [ Time Frame: 24 weeks, 48 weeks and 96 weeks ] [ Designated as safety issue: No ]
    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: 48 weeks and 96 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum


Estimated Enrollment: 3435
Study Start Date: December 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726439

Contacts
Contact: For Site information please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial site that are recruiting have contact information at this time

  Hide Study Locations
Locations
China, Beijing
Local Institution Recruiting
Beijing, Beijing, China, 100050
Contact: Site 001         
China, Chongqing
Local Institution Recruiting
Chongqing, Chongqing, China, 400038
Contact: Site 044         
Local Institution Recruiting
Chongqing, Chongqing, China, 710032
Contact: Site 052         
China, Fujian
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Fuzhou, Fujian, China, 350000
Contact: Site 022         
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Quanzhou, Fujian, China, 362002
Contact: Site 023         
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Xiamen, Fujian, China, 1361009
Contact: Site 024         
China, Guangdong
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Foshan, Guangdong, China, 528000
Contact: Site 035         
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Foshan, Guangdong, China, 528000
Contact: Site 036         
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Shenzhen, Guangdong, China, 528000
Contact: Site 037         
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Shenzhen, Guangdong, China, 528000
Contact: Site 054         
China, Guangxi
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Nanning, Guangxi, China, 530000
Contact: Site 061         
China, Guizhou
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Guiyang, Guizhou, China, 550000
Contact: Site 064         
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Guiyang, Guizhou, China, 55000
Contact: Site 065         
China, Hainan
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Haikou, Hainan, China, 570100
Contact: Site 062         
China, Hebei
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Baoding, Hebei, China, 071000
Contact: Site 008         
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Shijiazhuang, Hebei, China, 050000
Contact: Site 009         
China, Heilongjiang
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Daqing, Heilongjiang, China, 163461
Contact: Site 015         
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Haerbin, Heilongjiang, China, 150086
Contact: Site 014         
China, Henan
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Zhengzhou, Henan, China, 430000
Contact: Site 039         
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Zhengzhou, Henan, China, 450000
Contact: Site 040         
China, Hubei
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Shiyan, Hubei, China, 430000
Contact: Site 068         
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Wuhan, Hubei, China, 430022
Contact: Site 030         
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Wuhan, Hubei, China, 430032
Contact: Site 029         
China, Hunan
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Changsha, Hunan, China, 410008
Contact: Site 032         
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Changsha, Hunan, China, 410013
Contact: Site 033         
Local Institution Recruiting
Changsha, Hunan, China, 410006
Contact: Site 053         
China, Inner Mongolia
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Erdos, Inner Mongolia, China, 17000
Contact: Site 059         
China, Jiangsu
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Changshu, Jiangsu, China, 215500
Contact: Site 021         
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Changzhou, Jiangsu, China, 213001
Contact: Site 016         
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Nanjing, Jiangsu, China, 210000
Contact: Site 017         
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Nanjing, Jiangsu, China, 210000
Contact: Site 020         
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Suzhou, Jiangsu, China, 215000
Contact: Site 019         
China, Jiangxi
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Nangchang, Jiangxi, China, 330006
Contact: Site 049         
China, Jilin
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Changchun, Jilin, China, 130000
Contact: Site 011         
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Changchun, Jilin, China, 130000
Contact: Site 056         
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Yanji, Jilin, China, 133000
Contact: Site 058         
China, Liaoning
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Dalian, Liaoning, China, 116001
Contact: Site 012         
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Fushun, Liaoning, China, 113000
Contact: Site 057         
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Shengyang, Liaoning, China
Contact: Site 051         
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Shenyang, Liaoning, China, 110006
Contact: Site 013         
China, Ningxia
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Yinchuan, Ningxia, China, 750000
Contact: Site 067         
China, Shandong
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Jinan, Shandong, China, 250000
Contact: Site 002         
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Jinan, Shandong, China, 250000
Contact: Site 048         
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Jinan, Shandong, China, 250000
Contact: Site 005         
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Qingdao, Shandong, China, 266000
Contact: Site 003         
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Yantai, Shandong, China, 264001
Contact: Site 004         
China, Shanxi
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Taiyuan, Shanxi, China, 30000
Contact: Site 055         
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Taiyuan, Shanxi, China, 030000
Contact: Site 010         
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Xi'an, Shanxi, China, 710061
Contact: Site 043         
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Xi'an, Shanxi, China, 710032
Contact: Site 050         
China, Sichuan
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Chengdu, Sichuan, China, 610072
Contact: Site 045         
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Chengdu, Sichuan, China, 610041
Contact: Site 046         
Local Institution Recruiting
Chengdu, Sichuan, China, 610072
Contact: Site 047         
China, Tianjin
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Tianjin, Tianjin, China, 300000
Contact: Site 006         
Local Institution Active, not recruiting
Tianjin, Tianjin, China, 300000
China, Xinjiang
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Urumqi, Xinjiang, China, 830001
Contact: Site 066         
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Wulumuqi, Xinjiang, China, 830001
Contact: Site 041         
Local Institution Recruiting
Wulumuqi, Xinjiang, China, 830052
Contact: Site 042         
China, Zhejiang
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Hangzhou, Zhejiang, China, 310006
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Hangzhou, Zhejiang, China, 310023
Contact: Site 027         
Local institution Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Site 069         
Local Institution Not yet recruiting
Jinghua, Zhejiang, China, 300000
Contact: Site 070         
Local Institution Recruiting
Ningbo, Zhejiang, China, 315010
Contact: Site 028         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01726439     History of Changes
Other Study ID Numbers: AI463-952
Study First Received: November 6, 2012
Last Updated: November 25, 2013
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on April 17, 2014