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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03345498 |
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Date of registration:
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31/10/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Entecavir for Decompensated HBV Cirrhosis
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Scientific title:
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Study to Compare Virological Response to 0.5 mg Daily Versus 1.0 mg Daily Oral Doses of Entecavir in Chronic Hepatitis B Virus Infection Related Decompensated Cirrhosis |
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Date of first enrolment:
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January 1, 2017 |
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Target sample size:
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32 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03345498 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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India
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Contacts
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Name:
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Amit Goel, DM |
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Address:
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Telephone:
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Email:
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Affiliation:
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Associate Professor, Gastroenterology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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.
Age minimum:
19 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Liver Cirrhosis
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Hepatitis B
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Intervention(s)
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Drug: Entecavir
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Primary Outcome(s)
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Percent reduction in quantitative HBV DNA levels at 2 weeks post-treatment
[Time Frame: 2 weeks from start of ETV treatment]
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Percent reduction in quantitative HBV DNA levels at 4 weeks post-treatment
[Time Frame: 4 weeks from start of ETV treatment]
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Secondary Outcome(s)
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Percent reduction in quantitative HBV DNA levels at 8, 12 and 24 weeks post-treatment
[Time Frame: 8, 12 and 24 weeks from start of ETV treatment]
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Change in disease severity as assessed by change in CTP score and change in MELD score
[Time Frame: 24 weeks from start of ETV treatment]
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Secondary ID(s)
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2016-140-IMP-93
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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