Status:
COMPLETED
Entecavir for Decompensated HBV Cirrhosis
Lead Sponsor:
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Conditions:
Hepatitis B
Liver Cirrhosis
Eligibility:
All Genders
19+ years
Brief Summary
Entecavir (ETV) and tenofovir (TDF) are the first-line drugs for treatment of chronic hepatitis B virus (HBV) infection. Chronic HBV infection gradually progress to liver cirrhosis. Over time, as live...
Detailed Description
Background Chronic infection with hepatitis B virus (HBV), if untreated, may progress to liver cirrhosis, portal hypertension and hepatocellular carcinoma. Currently, oral administration of one of the...
Eligibility Criteria
Inclusion
- Participants with decompensated liver cirrhosis and
- Replicative HBV infection (HBsAg positive, serum HBV DNA titer \>100,000 IU/mL) regardless of HBeAg and anti-HBe test results
Exclusion
- prior exposure to NAs or other specific treatment for HBV infection (e.g. pegylated interferon)
- hepatocellular carcinoma
- co-infection with any other hepatotropic viruses or HIV
- acute-on-chronic liver failure as defined by Asia-Pacific Association for the Study of Liver criteria
- significant alcohol intake or another concomitant hepatobiliary disease
- expected survival below 4 weeks (e.g. hemodynamic instability, active sepsis, hepatorenal syndrome, etc)
- use of immunosuppressive medication or
- portal vein thrombosis.
Key Trial Info
Start Date :
January 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03345498
Start Date
January 1 2017
End Date
December 31 2018
Last Update
September 24 2019
Active Locations (1)
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1
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, India, 226014