Status:
ACTIVE_NOT_RECRUITING
Effectiveness of Antiviral Treatment in Cirrhotic Patients with Low-level Hepatitis B Virus DNA Levels
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
National Evidence-Based Healthcare Collaborating Agency
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
30-80 years
Phase:
PHASE4
Brief Summary
Multicenter, Open-label, Single arm Trial with Matched Historical controls. Male and female adults with compensated liver cirrhosis due to chronic hepatitis B virus infection who have low-level viremi...
Detailed Description
1. This clinical trial is a multicenter, open label, single arm study in cirrhotic chronic hepatitis B patients with low-level viremia. 2. Approximately 200 subjects meeting eligibility criteria will ...
Eligibility Criteria
Inclusion
- Willing and able to provide written informed consent prior to study entry
- Age ≥30 years and ≤80 years at the time of screening
- Chronic hepatitis B infection defined as HBsAg (+) or HBV DNA (+) for at least 6 months prior to the Screening visit, or medical records indication a chronic hepatitis B virus infection by meeting all of the following criteria at the time of screening. (1) HBsAg (+), (2) HBV DNA (+), and (3) HBcAb IgM (-)
- Either HBeAg (+) or HBeAg (-)
- Serum HBV DNA levels ≥20 IU/mL and \<2,000 IU/mL at the time of screening
- Evidence of liver cirrhosis defined as meeting any of the following criteria:
- Radiological evidence of liver cirrhosis by ultrasound, CT, or MRI
- Platelet count \<150,000 /mm3
- Presence of esophageal or gastric varices by endoscopy in 2 years before the timing of screening
- Clinically significant portal hypertension
- Fibroscan ≥12.0 kPa (if the test was done in 6 months before the time of screening)
- Estimated creatinine clearance ≥30 ml/min (by calculation of creatinine clearance or using the CKD-EPI equation)
- Ability to comply with all study requirements
Exclusion
- Confirmed known co-infection with HCV, HIV, or HDV
- Current alcohol (60g/day) or substance abuse judged by the investigator that will potentially interfere with subject compliance
- Any history of, or current evidence of, clinical hepatic decompensation (e.g., ascites, encephalopathy, variceal hemorrhage, or Child-Pugh score of ≥8, with the exception of Gilbert syndrome) in 1 year before the time of screening
- Currently on or have received therapy with Interferon or immunosuppressant (including systemic chemotherapy) within 12 months prior to the screening
- Requirement for chronic use of systemic immunosuppressant including, but not limited to, corticosteroid (prednisone equivalent of \>40 mg/day for \>2 weeks), azathioprine, or monoclonal antibodies
- Received solid organ or bone marrow transplant
- History of severe, life-threatening or other significant sensitivity to any excipients of the study drugs
- Any other clinical conditions (cardiovascular, respiratory, neurologic, or renal conditions) or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements.
- Currently on or have received antiviral treatment for ≥ 2 weeks within 6 months prior to the screening
- History or current evidence of hepatocellular carcinoma (HCC), or high α-fetoprotein (AFP) \> 20 ng/mL. But, the patients with AFP \> 20 ng/mL can be enrolled if AFP shows decreasing trend and there is no evidence of HCC by dynamic CT or MRI)
- Malignancy other than hepatocellular carcinoma within the 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (within 2 years prior to screening with confirmation of no evidence of disease). Subjects under evaluation for possible malignancy are not eligible.
- Concurrent enrollment in another clinical study for other type of antiviral treatment for CHB or immune modulatory drug within 3 months prior to randomization, participation to an observational (non-interventional) clinical studies or interventional studies not using anti-HBV or immune modulatory drugs, or during the follow-up period of an interventional study are not exclusion criteria.
- Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study
Key Trial Info
Start Date :
August 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04780204
Start Date
August 23 2021
End Date
December 1 2027
Last Update
October 9 2024
Active Locations (10)
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1
Kyungpook National University Hospital
Daegu, South Korea
2
Asan Medical Center
Seoul, South Korea
3
Chung-Ang University Hospital
Seoul, South Korea
4
Konkuk University Hospital
Seoul, South Korea