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

NCT04646928 | Unknown

• 1 other identifier: EN-REACH
• Study Type: observational
• Target: 245
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• 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

  5 years

Secondary Outcomes (4)

• Overall Survival

  5 years

• Incidence of ascites, esophageal, gastric variceal bleeding, hepatic encephalopathy (hepatic coma)

  5 years

• Incidence of virologic response, virologic breakthrough

  5 years

• Incidence of cirrhosis regression

  5 years

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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))

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• CHA University: lead
• Dong-A ST Co., Ltd.: collaborator

Study Sites (11)

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, South Korea

RECRUITING

Soon Chun Hyang University Hospital Cheonan

Cheonan, South Korea

RECRUITING

Bundang Jesaeng Hospital

Gyeonggi-do, South Korea

RECRUITING

Catholic University of Korea, Uijeongbu ST. Mary's Hospital

Gyeonggi-do, South Korea

RECRUITING

CHA Bundang Medical Center

Gyeonggi-do, South Korea

RECRUITING

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Gachon University, Donginchoen Gil Hospital

Sŏngnam, South Korea

RECRUITING

Ajou University Hospital

Suwon, South Korea

RECRUITING

The Catholic University of Korea, St. Vincent's Hospital

Suwon, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Hepatitis B virus (HBV) DNA level from patient blood sample

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• SungKyu Hwang, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SungKyu Hwang, MD

CONTACT

+82-1577-4488; sghwang@cha.ac.kr

Jinyeong Lee

CONTACT

+82-1577-4488; or_ange@naver.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2020
• First Posted: November 30, 2020
• Study Start: March 17, 2017
• Primary Completion: May 28, 2022
• Study Completion: August 26, 2022
• Last Updated: November 30, 2020

Record last verified: 2020-11

Locations

KR (11)