Effect of Entecavir Treatment on Regression and Disease Outcome in HBV-induced Liver Fibrosis and Cirrhosis Patients

NCT02849132 | Unknown Phase 4

• 1 other identifier: 2016ZX10002011
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 20

Brief Summary

Patients who have completed 2 years follow-up of the past National 12th Five-Year Major Project on Infectious Diseases will receive another 8 years treatment with entecavir (10 years in total). Collect serology, imaging, and other clinical data to evaluate the incidence and mortality of decompensated cirrhosis and hepatocellular carcinoma. Understand the effects of long-term antiviral therapy on HBV-induced liver fibrosis/cirrhosis.

Conditions

Hepatitis B; Liver Cirrhosis

Outcome Measures

Primary Outcomes (2)

• Fibrosis regression rate

  Ishak fibrosis score decrease after long-term treatment

  year 3

• Cumulative incidence of liver decompensation

  Cumulative incidence of liver decompensation (including ascites, hepatic encephalopathy, esophageal varices bleeding and Hepatocellular Carcinoma) and death after long-term treatment

  year 8

Secondary Outcomes (8)

• Virological response

  year 3, 5, 7 and 10

• Aminotransferase response

  year 3, 5, 7 and 10

• HBeAg loss or HBeAg seroconversion

  year 2, 5, 7 and 10

• HBsAg loss or HBsAg seroconversion rate

  year 2, 5, 7 and 10

• Dynamic changes of Child-Pugh score

  year 3, 5, 7 and 10

Study Arms (1)

Treatment group

EXPERIMENTAL

entecavir oral，0.5mg daily for 8 years

Drug: Entecavir

Interventions

Entecavir DRUG

oral entecavir 0.5mg daily for 8 years

Treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Subjects who completed the 2 years of entecavir-based therapy in Regress study; Subjects who are willing to participate the extension study.

You may not qualify if:

• \- Any complication of severe heart, lung, kidney, brain, blood diseases or other important systematic diseases; Pregnant women; Subjects who could not compliance with the protocol judged by investigators; Subjects who are not suitable for the study judged by investigators.

Sponsors & Collaborators

• Beijing Friendship Hospital: lead
• Peking University People's Hospital: collaborator
• Fudan University: collaborator
• Affiliated Hospital of Yanbian University: collaborator
• Shanghai Public Health Clinical Center: collaborator
• Beijing YouAn Hospital: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (20)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

302 Military Hospital Of China

Beijing, Beijing Municipality, 100039, China

Location

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 100050, China

Location

Beijing YouAn Hospital, Capital Medical University

Beijing, Beijing Municipality, 100069, China

Location

NanfangHospital,Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050051, China

Location

Shijiazhuang Fifth Hospital

Shijiazhuang, Hebei, 50021, China

Location

Tongji Hospital, Tongji Medical College , Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

The Affiliated Hospital of Yanbian University

Yanji, Jilin, 133000, China

Location

Renji Hospital, Shanghai Jiao Tong University, School of Medicine

Shanghai, Shanghai Municipality, 200032, China

Location

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 201508, China

Location

The First Hospital of Shanxi Medical University

Taiyuan, Shanxi, 30001, China

Location

Xijing Hospital, Fourth Military Medical University

Xi’an, Shanxi, 710032, China

Location

Tianjin Xiqing Hospital

Tianjin, Tianjin Municipality, 300380, China

Location

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310016, China

Location

Tianjin Third Central Hospital

Tianjin, 300170, China

Location

Related Publications (6)

• Arvaniti V, D'Amico G, Fede G, Manousou P, Tsochatzis E, Pleguezuelo M, Burroughs AK. Infections in patients with cirrhosis increase mortality four-fold and should be used in determining prognosis. Gastroenterology. 2010 Oct;139(4):1246-56, 1256.e1-5. doi: 10.1053/j.gastro.2010.06.019. Epub 2010 Jun 14.

  PMID: 20558165 BACKGROUND

• Liaw YF, Sung JJ, Chow WC, Farrell G, Lee CZ, Yuen H, Tanwandee T, Tao QM, Shue K, Keene ON, Dixon JS, Gray DF, Sabbat J; Cirrhosis Asian Lamivudine Multicentre Study Group. Lamivudine for patients with chronic hepatitis B and advanced liver disease. N Engl J Med. 2004 Oct 7;351(15):1521-31. doi: 10.1056/NEJMoa033364.

  PMID: 15470215 BACKGROUND

• Zhang J, Chen S, Zhou J, Wang B, Wu X, Xu X, Zhao X, Kong Y, Ou X, Sun Y, You H. Serial Liver Stiffness Measurement and Serum Biomarkers Are Not Strong Predictors of the Regression of Fibrosis among Chronic Hepatitis B Patients Receiving Antiviral Therapy Based on Triple Liver Biopsies. Gut Liver. 2025 Nov 15;19(6):889-899. doi: 10.5009/gnl250008.

  PMID: 41234032 DERIVED

• Wu X, Hong J, Zhou J, Sun Y, Li L, Xie W, Piao H, Xu X, Jiang W, Feng B, Chen Y, Xu M, Cheng J, Meng T, Wang B, Chen S, Kong Y, Ou X, You H, Jia J. Health-related quality of life improves after entecavir treatment in patients with compensated HBV cirrhosis. Hepatol Int. 2021 Dec;15(6):1318-1327. doi: 10.1007/s12072-021-10240-4. Epub 2021 Nov 29.

  PMID: 34843068 DERIVED

• Wu X, Zhou J, Sun Y, Ding H, Chen G, Xie W, Piao H, Xu X, Jiang W, Ma H, Ma A, Chen Y, Xu M, Cheng J, Xu Y, Meng T, Wang B, Chen S, Shi Y, Kong Y, Ou X, You H, Jia J. Prediction of liver-related events in patients with compensated HBV-induced cirrhosis receiving antiviral therapy. Hepatol Int. 2021 Feb;15(1):82-92. doi: 10.1007/s12072-020-10114-1. Epub 2021 Jan 18.

  PMID: 33460002 DERIVED

• Yang JM, Chen LP, Wang YJ, Lyu B, Zhao H, Shang ZY, Li J, Fan ZY, Wu SD, Ming X, Li X, Huang SP, Cheng JL. Entecavir add-on Peg-interferon therapy plays a positive role in reversing hepatic fibrosis in treatment-naive chronic hepatitis B patients: a prospective and randomized controlled trial. Chin Med J (Engl). 2020 Jul 20;133(14):1639-1648. doi: 10.1097/CM9.0000000000000857.

  PMID: 32568867 DERIVED

MeSH Terms

Conditions

Hepatitis B; Liver Cirrhosis

Interventions

entecavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiaojuan Ou

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice-Director of Liver Research Center

Study Record Dates

• First Submitted: July 22, 2016
• First Posted: July 29, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2025
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

CN (20)