The Efficacy and Safety of Nucleos(t)Ide Analogues in the Treatment of HBV-related Acute-on-chron… (NCT03640728) | Clinical Trial Compass
UnknownNot Applicable
The Efficacy and Safety of Nucleos(t)Ide Analogues in the Treatment of HBV-related Acute-on-chronic Liver Failure
China200 participantsStarted 2019-01-25
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. age 18-70 years, male or female.
✓. HBsAg positive at least 6 months or more, HBeAg positive or negative.
✓. Serum HBV DNA positive (Serum HBV DNA should be determined by the PCR assay at the local laboratory at screening for this study)
✓. Recent development of increasing jaundice (a total serum bilirubin concentration of above 85μmol/L) and coagulopathy (INR ≥1.5 or prothrombin activity\<40%)
✓. Recent development of complications such as hepatic encephalopathy, or abrupt and obvious increase in ascites, or spontaneous bacterial peritonitis, or hepatorenal syndrome.
✓. Patient is willing and able to comply with the study drug regimen and all other study requirements.
✓. The patient is willing and able to provide written informed consent to participate in the study.
Exclusion criteria
✕. Patient has concomitant other chronic viral infection (HCV or HIV)
✕
What they're measuring
1
Overall survival of ACLF subjects
Timeframe: study day 1 through week 48
Trial details
NCT IDNCT03640728
SponsorFirst Affiliated Hospital Xi'an Jiaotong University
. Patient has evidence of renal insufficiency defined as serum creatinine \> 1.5 mg/dL
✕. Patient has medical condition that requires concurrent use of systemic prednisolone or other immunosuppressive agent (including chemotherapeutic agent)
✕. Patient is pregnant or breastfeeding or willing to be pregnant
✕. Patient has one or more additional known primary or secondary causes of liver disease, other than hepatitis B (e.g., alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, alpha-1 antitrypsin deficiency, Wilson's Disease, other congenital or metabolic conditions affecting the liver, congestive heart failure or other severe cardiopulmonary disease, etc.).
✕. A history of treated malignancy (other than hepatocellular carcinoma) is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding three years.
✕. Active ethanol/drug abuse/psychiatric problems such as major depression, schizophrenia, bipolar illness, obsessive-compulsive disorder, severe anxiety, personality disorder that might interfere with participation in the study.
✕. Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance.