Study of Entecavir for Reducing the Risk of Hepatocellular Carcinoma in Chronic Hepatitis B Patients
NCT ID: NCT04646928
Last Updated: 2020-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
245 participants
OBSERVATIONAL
2017-03-17
2022-08-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
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
20 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dong-A ST Co., Ltd.
INDUSTRY
CHA University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
SungKyu Hwang, MD
Role: PRINCIPAL_INVESTIGATOR
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, , South Korea
Soon Chun Hyang University Hospital Cheonan
Cheonan, , South Korea
Bundang Jesaeng Hospital
Gyeonggi-do, , South Korea
Catholic University of Korea, Uijeongbu ST. Mary's Hospital
Gyeonggi-do, , South Korea
CHA Bundang Medical Center
Gyeonggi-do, , South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Gachon University, Donginchoen Gil Hospital
Sŏngnam, , South Korea
Ajou University Hospital
Suwon, , South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EN-REACH
Identifier Type: -
Identifier Source: org_study_id