Study of Entecavir for Reducing the Risk of Hepatocellular Carcinoma in Chronic Hepatitis B Patients

November 22, 2020 updated by: CHA University

Efficacy of Entecavir for Reducing the Risk of Hepatocellular Carcinoma in Chronic Hepatitis B Patients With Compensated Cirrhosis and Low Viral Load: a Multicenter, Prospective Study

To analyze the incidence of liver cancer after entecavir administration among patients with low viral load and cirrhosis due to chronic hepatitis B infection.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

To analyze the incidence of liver cancer after entecavir administration among patients with low viral load (HBV DNA titer<2,000 IU/mL (104 copies/mL)) and cirrhosis due to chronic hepatitis B infection.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
245

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Bucheon, Korea, Republic of
        • Recruiting
        • Soon Chun Hyang University Hospital Bucheon
      • Cheonan, Korea, Republic of
        • Recruiting
        • Soon Chun Hyang University Hospital Cheonan
      • Gyeonggi-do, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
      • Gyeonggi-do, Korea, Republic of
        • Recruiting
        • Bundang Jesaeng Hospital
      • Gyeonggi-do, Korea, Republic of
        • Recruiting
        • Catholic University of Korea, Uijeongbu St. Mary's Hospital
      • Gyeonggi-do, Korea, Republic of
        • Recruiting
        • CHA Bundang Medical Center
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Center
      • Suwon, Korea, Republic of
        • Recruiting
        • The Catholic University of Korea, St. Vincent's Hospital
      • Suwon, Korea, Republic of
        • Recruiting
        • Ajou University Hospital
      • Sŏngnam, Korea, Republic of
        • Recruiting
        • Gachon University, Donginchoen Gil Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subject with Hepatitis B and liver cirrhosis displaying low viral load (HBV DNA titer <2,000 IU/mL (104 copies/mL))

Description

Inclusion Criteria:

  • A subject who has consented to participate in this clinical trial
  • A subject aged between ≥20 to ≤75 years old
  • A subject with positive HBsAg for more than 24 weeks (may be confirmed by medical history)
  • HBV DNA ≥26 IU/mL or ≤ 2,000 IU/mL at the time of screening

  • A subject diagnosed with cirrhosis with one of the following:

    1. Subject with confirmed liver cirrhosis in the screening period or liver biopsy performed within 1 year from the time of screening (METAVIR score> 3, ISHAK score> 4)
    2. Two or more confirmed typical findings suggesting liver cirrhosis from imaging such as liver ultrasound and CT performed within 24 weeks of screening or during screening period (nodularity of the liver surface, atrophy of the inner right and left lobes, thickening of the left and tail lobes, hepatic portal system expansion of surrounding space, expansion of hepatic portal system (>1.3 cm) and splenomegaly (>12 cm))
    3. One or more confirmed typical findings suggesting liver cirrhosis from imaging such as liver ultrasound and CT performed within 24 weeks of screening or during screening period (nodularity of the liver surface, atrophy of the inner right and left lobes, thickening of the left and tail lobes, hepatic portal system expansion of surrounding space, expansion of hepatic portal system (>1.3 cm) and splenomegaly (>12 cm)) or findings including the following:
  • Confirmed thrombocytopenia (<150,000/mm3) at the screening period or blood tests conducted within 24 weeks from the time of screening
  • Confirmed identification of esophageal varicose veins or gastric varicose veins by endoscopy or CT performed within one year from the screening period or at screening
  • Liver stiffness measurement (LSM)> 11.5 kilopascal (kPa) (F4) as a result of liver fibrosis scan, performed within 1 year from screening period or at screening

Exclusion Criteria:

  • A subject with non compensated cirrhosis and any of the following:

    1. Serum bilirubin> 3 mg/dL
    2. Prothrombin time> 6 seconds prolonged or International Normalized Ratio (INR) >1.6
    3. Serum albumin <2.8 g/dL
    4. History of ascites, varicose bleeding, hepatorenal syndrome, hepatic encephalopathy (hepatic coma) requiring treatment within 5 years from screening
    5. Child-Pugh score ≥ 8
  • A subject who have received interferon or other oral nucleic acid analogues (nucleos(t)ide analogues) (However, if the treatment duration was less than 30 days in the past and the treatment was treated 24 weeks before the screening, participation is possible)
  • A subject diagnosed with liver cancer in the past or present
  • Renal function decline (creatinine clearance <50 mL/min, estimated by the Cockcroft-Gault formula)
  • A subject with serious concomitant diseases such as congestive heart failure, chronic kidney disease, blood disease, or malignant tumors in the past or present
  • A subject infected with hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
  • A subject who consume excessive alcohol (men: 30g/day or more, women: 20g/day or more)
  • A subject with liver diseases such as autoimmune hepatitis, hemochromatosis, or Wilson's disease
  • Pregnant or breastfeeding women
  • Previous organ transplant recipients
  • A subject unable to complete the clinical trial or to have any medical condition that may interfere with the evaluation of the efficacy of this clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
5-year Cumulative hepatocellular carcinoma incidence
Time Frame: 5 years
Compare the difference in the 5-year cumulative incidence of hepatocellular carcinoma in patients with chronic hepatitis B and cirrhosis with entecavir and control
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 5 years
Compare the difference in the 5-year incidence overall survival in patients with chronic hepatitis B and cirrhosis with entecavir and control
5 years
Incidence of ascites, esophageal, gastric variceal bleeding, hepatic encephalopathy (hepatic coma)
Time Frame: 5 years
Compare the difference in the 5-year incidence of ascites/esophageal/gastric variceal bleeding/hepatic encephalopathy (hepatic coma) in patients with chronic hepatitis B and cirrhosis with entecavir and control
5 years
Incidence of virologic response, virologic breakthrough
Time Frame: 5 years
Compare the difference in the 5-year incidence incidence of virologic response and virologic breakthrough in patients with chronic hepatitis B and cirrhosis with entecavir and control
5 years
Incidence of cirrhosis regression
Time Frame: 5 years
Compare the difference in the 5-year incidence of cirrhosis regression in patients with chronic hepatitis B and cirrhosis with entecavir and control
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CHA University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dong-A ST Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: SungKyu Hwang, MD, Principal Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 17, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 28, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 26, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 30, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EN-REACH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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