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

Chronic Hepatitis B Clinical Trial

— EVOLVE  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01726439
• Other study ID #: AI463-952
• Status: Completed
• Start date: December 2012
• Est. completion date: December 31, 2018

Study information

• Verified date: July 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

Sampling Method: Consecutive patient sampling

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3434
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
China	Local Institution	Baoding	Hebei
China	Local Institution	Beijing	Beijing
China	Local Institution	Changchun	Jilin
China	Local Institution	Changsha	Hunan
China	Local Institution	Changsha	Hunan
China	Local Institution	Changsha	Hunan
China	Local Institution	Changshu	Jiangsu
China	Local Institution	Changzhou	Jiangsu
China	Local Institution	Chengdu	Sichuan
China	Local Institution	Chengdu	Sichuan
China	Local Institution	Chongqing	Chongqing
China	Local Institution	Chongqing	Chongqing
China	Local Institution	Dalian	Liaoning
China	Local Institution	Daqing	Heilongjiang
China	Local Institution	Erdos	Inner Mongolia
China	Local Institution	Foshan	Guangdong
China	Local Instution	Fushun	Liaoning
China	Local Institution	Fuzhou	Fujian
China	Local institution	Guiyang	Guizhou
China	Local Institution	Guiyang	Guizhou
China	Local Institution	Haerbin	Heilongjiang
China	Local Institution	Haikou	Hainan
China	Local institution	Hangzhou	Zhejiang
China	Local Institution	Hangzhou	Zhejiang
China	Local Institution	Hangzhou	Zhejiang
China	Local Institution	Jinan	Shandong
China	Local Institution	Jinghua	Zhejiang
China	Local Institution	Nangchang	Jiangxi
China	Local Institution	Nanjing	Jiangsu
China	Local Institution	Nanning	Guangxi
China	Local Institution	Ningbo	Zhejiang
China	Local Institution	Qingdao	Shandong
China	Local Institution	Quanzhou	Fujian
China	Local Institution	Shengyang	Liaoning
China	Local Institution	Shenyang	Liaoning
China	Local Institution	Shenzhen	Guangdong
China	Local Institution	Shijiazhuang	Hebei
China	Local Institution	Shiyan	Hubei
China	Local Institution	Suzhou	Jiangsu
China	Local Institution	Taiyuan	Shanxi
China	Local Institution	Taiyuan	Shanxi
China	Local Institution	Tianjin	Tianjin
China	Local Institution	Urumqi	Xinjiang
China	Local Institution	Wuhan	Hubei
China	Local Institution	Wuhan	Hubei
China	Local Institution	Wulumuqi	Xinjiang
China	Local Institution	Wulumuqi	Xinjiang
China	Local Institution	Xi'an	Shanxi
China	Local Institution	Xi'an	Shanxi
China	Local Institution	Xiamen	Fujian
China	Local institution	Yanji	Jilin
China	Local Institution	Yantai	Shandong
China	Local Institution	Yinchuan	Ningxia
China	Local Institution	Zhengzhou	Henan
China	Local Institution	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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	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
Secondary	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
Secondary	Cumulative incidence of clinical outcome (eg, HCC, death, decompensated cirrhosis) in ETV arm versus LAM-based and other treatment arms		48 weeks, 96 weeks, 144 weeks, 192 weeks and 240 weeks

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