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

NCT02849132 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2021-04-28

No results posted yet for this study

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

Interventions

DRUG

Entecavir

oral entecavir 0.5mg daily for 8 years

Sponsors & Collaborators

  • Peking University People's Hospital

    collaborator OTHER
  • Fudan University

    collaborator OTHER
  • Affiliated Hospital of Yanbian University

    collaborator UNKNOWN
  • Shanghai Public Health Clinical Center

    collaborator OTHER_GOV
  • Beijing YouAn Hospital

    collaborator OTHER
  • Nanfang Hospital, Southern Medical University

    collaborator OTHER
  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER
  • Beijing Friendship Hospital

    lead OTHER

Principal Investigators

  • Xiaojuan Ou · Beijing Friendship Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2023-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02849132 on ClinicalTrials.gov