Chronic Hepatitis BNCT04646928
Study of Entecavir for Reducing the Risk of Hepatocellular Carcinoma in Chronic Hepatitis B Patients
An observational study of Chronic Hepatitis B, run by CHA University at 11 sites in South Korea.
Trial summary
To analyze the incidence of liver cancer after entecavir administration among patients with low viral load and cirrhosis due to chronic hepatitis B infection. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Chronic Hepatitis B
- How many people
- 245 participants
- Where
- 11 sitesSouth Korea
- Study dates
- 17 Mar 2017to 26 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject with Hepatitis B and liver cirrhosis displaying low viral load (HBV DNA titer <2,000 IU/mL (104 copies/mL))
Who may be able to join
- 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:
- 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)
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- 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))
- 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
Who cannot join
- A subject with non compensated cirrhosis and any of the following:
- Serum bilirubin> 3 mg/dL
- Prothrombin time> 6 seconds prolonged or International Normalized Ratio (INR) >1.6
- Serum albumin <2.8 g/dL
- History of ascites, varicose bleeding, hepatorenal syndrome, hepatic encephalopathy (hepatic coma) requiring treatment within 5 years from screening
- Child-Pugh score ≥ 8
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- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
South Korea11 sites, 11 recruiting
- Recruiting
Soon Chun Hyang University Hospital Bucheon
Bucheon-si
- Recruiting
Soon Chun Hyang University Hospital Cheonan
Cheonan
- Recruiting
Bundang Jesaeng Hospital
Gyeonggi-do
- Recruiting
Catholic University of Korea, Uijeongbu ST. Mary's Hospital
Gyeonggi-do
- Recruiting
CHA Bundang Medical Center
Gyeonggi-do
- Recruiting
Seoul National University Bundang Hospital
Gyeonggi-do
- Recruiting
Samsung Medical Center
Seoul
- Recruiting
Seoul National University Hospital
Seoul
- Recruiting
Gachon University, Donginchoen Gil Hospital
Sŏngnam
- Recruiting
Ajou University Hospital
Suwon
- Recruiting
The Catholic University of Korea, St. Vincent's Hospital
Suwon
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Hepatitis B
- Medical subject headings
- Hepatitis B, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year Cumulative hepatocellular carcinoma incidence
Compare the difference in the 5-year cumulative incidence of hepatocellular carcinoma in patients with chronic hepatitis B and cirrhosis with entecavir and control
Measured: 5 years
Secondary outcomes (4)
Overall Survival
Compare the difference in the 5-year incidence overall survival in patients with chronic hepatitis B and cirrhosis with entecavir and control
Measured: 5 years
Incidence of ascites, esophageal, gastric variceal bleeding, hepatic encephalopathy (hepatic coma)
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
Measured: 5 years
Incidence of virologic response, virologic breakthrough
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
Measured: 5 years
Incidence of cirrhosis regression
Compare the difference in the 5-year incidence of cirrhosis regression in patients with chronic hepatitis B and cirrhosis with entecavir and control
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start17 Mar 2017
- Primary completion28 May 2022 (estimated)
- Study completion26 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 245 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHA University
- Sponsor type
- University, hospital or other
- Collaborators
- Dong-A ST Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- SungKyu Hwang, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646928
- Sponsor's protocol ID
- EN-REACH
- Status last verified
- Nov 2020
- First submitted
- 22 Nov 2020
- Last updated
- 30 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04646928
- Acronym / sponsor ID
- EN-REACH
- Conditions
- Chronic Hepatitis B
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 245 participants (estimated)
- Lead sponsor
- CHA UniversityUniversity, hospital or other
- Collaborators
- Dong-A ST Co., Ltd.
- Study start
- 17 Mar 2017 (actual)
- Primary completion
- 28 May 2022 (estimated)
- Study completion
- 26 Aug 2022 (estimated)
- First posted
- 30 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To analyze the incidence of liver cancer after entecavir administration among patients with low viral load and cirrhosis due to chronic hepatitis B infection.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject with Hepatitis B and liver cirrhosis displaying low viral load (HBV DNA titer <2,000 IU/mL (104 copies/mL))
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (16 listed)
- A subject with non compensated cirrhosis and any of the following:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Overall Survival
Time frame: 5 years
Incidence of ascites, esophageal, gastric variceal bleeding, hepatic encephalopathy (hepatic coma)
Time frame: 5 years
Incidence of virologic response, virologic breakthrough
Time frame: 5 years
Incidence of cirrhosis regression
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SungKyu Hwang, MD principal investigator
Principal Investigator
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis B, run by CHA University at 11 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SungKyu Hwang, MD (+82-1577-4488, sghwang@cha.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year Cumulative hepatocellular carcinoma incidence (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2020.