An observational study in Hepatitis B, Virus Diseases and Liver Failure, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Status unknown at 11 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-02-09.
Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Observational
HBV-related acute-on-chronic liver failure (ACLF) is a clinical syndrome defined as acute hepatic insult with diagnosed or undiagnosed chronic liver disease. Current clinical guidelines advocate oral antiviral treatment in HBV-related ACLF. However, no conclusion on which nucleoside analogue is the most satisfactory drug for the treatment of HBV-related liver failure has not been reached yet. In this cohort study, the investigators will compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF), Tenofovir Disoproxil Fumarate (TDF) and entecavir (ETV) in HBV-related ACLF in China. In addition, the drug metabolism characteristics of TAF will be explored in such severe liver injury population of HBV-ACLF.
Potent antivirals like entecavir (ETV), Tenofovir Disoproxil Fumarate (TDF) and Tenofovir alafenamide (TAF) now are recommended as first-line therapy for patients with chronic HBV infection because of their significant suppression of viral replication and a high barrier to resistance. HBV-related acute-on-chronic liver failure (ACLF) is a clinical syndrome defined as acute hepatic insult with diagnosed or undiagnosed chronic liver disease. Only a limited number of medical treatments are available for ACLF. Although liver transplantation is a life-saving treatment for ACLF, the difficulty in finding a suitable donor and the high cost hinder its extensive clinical use.
The precise mechanism underlying the liver injury caused by HBV-related ACLF and the factors contributing to the progression of liver failure remain unknown. HBV DNA replication is one of the key factors causing the progression from liver damage to liver failure. Current clinical guidelines advocate oral antiviral treatment in HBV-related ACLF. However, the specific antiviral treatment for patients with liver failure remains unclear. In the past years, efficacy of nucleoside analogues, such as lamivudine, entecavir, telbivudine and tenofovir, for HBV-related liver failure has been reported. However, no conclusion on which nucleoside analogue is the most satisfactory drug for the treatment of HBV-related liver failure has not been reached yet.
In this cohort study, the investigators will compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF), Tenofovir Disoproxil Fumarate (TDF) and entecavir (ETV) in HBV-related ACLF in China. In addition, pharmacokinetic properties of TAF tablets will be explored in the study subjects.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's planned enrollment of 200 is below the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.
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All the patients received antivirals will be followed for at least 48 weeks and follow-up assessments were performed at week 1, 2, 3, 4, 12, 24 and 48.All the patients were detected Serum HBV DNA,HBV markers, including HBsAg, HBsAb, HBeAg, HBeAb and HBcAb, routine biochemical tests mainly including ALT,AST,TB and ALB.
Inclusion Criteria:All of below
Exclusion Criteria: Any of below
patients receive entecavir 0.5 mg/day orally.
Drug: Entecavir
patients receive Tenofovir Disoproxil Fumarate 300 mg/day orally.
Drug: Tenofovir disoproxil fumarate
patients receive Tenofovir alafenamide 25 mg/day orally.
Drug: Tenofovir Alafenamide
Tenofovir alafenamide 25 mg/day orally
Entecavir 0.5 mg/day orally
Tenofovir Disoproxil Fumarate 300 mg/day orally
Overall survival of ACLF subjects
Overall survival in subjects with acute-on-chronic liver failure will be summarized and compared with control subjects through study day 28 and week 48.
Time frame: study day 1 through week 48
Changes in serum HBV DNA levels
Time frame: at week 4 and 48 of treatment
Proportion of patients with hepatitis B e-Ag(HBe-Ag) loss or seroconversion
Time frame: at week 4 and 48 of treatment
Proportion of patients with HBs-Ag loss or seroconversion
Time frame: at week 4 and 48 of treatment
Proportion of patients with normal alanine aminotransferase(ALT)
Time frame: at week 4 and 48 of treatment
Liver function evaluation through Model for End-Stage Liver Disease (MELD) scores
Model for End-Stage Liver Disease(MELD) Score is calculated according to the equation:3.78×ln\[serum bilirubin (mg/dl)\] + 11.2×ln(INR) + 9.57×ln\[serum creatinine (mg/dL)\] + 6.43. Liver function improvement defined as the decline of total MELD score, whereas liver function deterioration defined as the rise of total MELD score. The risk of death increased when total MELD score above 25.
Time frame: at week 4 and 48 of treatment
Proportion of patients with virologic breakthrough
Virologic breakthrough is defined as the increase in serum HBV DNA by \>1 log10 (10-fold) above nadir after achieving virologic response as determined by at least 2 consecutive measurements of at least 2 weeks apart, during continued treatment
Time frame: at week 4 and 48 of treatment
Proportion of patients with complete virologic response
Virologic response is defined as the serum HBV DNA concentrations below 20 IU/mL
Time frame: at week 4 and 48 of treatment
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital Xi'an Jiaotong University