Effectiveness of Antiviral Treatment in Cirrhotic Patients with Low-level Hepatitis B Virus DNA L… (NCT04780204) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Effectiveness of Antiviral Treatment in Cirrhotic Patients with Low-level Hepatitis B Virus DNA Levels
South Korea600 participantsStarted 2021-08-23
Plain-language 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 viremia.
To assess the efficacy of Tenofovir Alafenamide (TAF) in reducing liver-related events (hepatocellular carcinoma, liver-related events and death, decompensated liver cirrhosis) in cirrhotic chronic hepatitis B patients with low-level viremia compared with matched historical controls.
Who can participate
Age range30 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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 criteria
✕. 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
What they're measuring
1
Cumulative incidence rate of composite clinical events
Timeframe: From randomization the composite clinical events will be collected every 6weeks , assessed up to 36months
. 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.