MedTrace Logo

Entecavir for Decompensated HBV Cirrhosis

NCT03345498 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 32

Last updated 2019-09-24

No results posted yet for this study

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 liver damage and cirrhosis advance, the illness progress to a stage termed as decompensated cirrhosis, characterized by development of one or more of serious, life-threatening complications (ascites, hepatic encephalopathy, variceal bleeding or jaundice). In HBV related decompensated cirrhosis, antiviral treatment is shown to provide benefit.

For HBV related decompensated cirrhosis, EVT is the drug of choice as it has been shown to be effective and safe. The usual dose of ETV for chronic HBV infection is 0.5 mg orally once daily. Somehow, the recommended dose of ETV for decompensated cirrhosis has been 1.0 mg/d. The literature provides no justification for using this double dose of ETV. Since 0.5 mg daily works well in other stages of disease, there is little reason why it should not work well even in treatment-naïve decompensated cirrhosis. Considering the limitations of available literature, physicians' are divided in their opinion about the drug dose and are prescribing either of the two doses of ETV for this group. Hence, there is a need to assess whether the usual 0.5 mg/d of ETV would work as well as the 1.0 mg/d dose of ETV in decompensated cirrhosis due to HBV infection.

Investigators planned this open-labeled observational study with objective to compare the efficacy of HBV suppression achieved using 0.5 mg daily and 1.0 mg daily of ETV in HBV-related decompensated cirrhosis by comparing the mean reduction in HBV DNA level from baseline after 24 weeks of treatment.

In present study investigators propose to enroll 15 participants in each group who has been started on either doses (0.5 mg and 1.0 mg) of entecavir and measure serum HBV DNA levels in blood specimens (5 ml) will be collected at different time points, i.e. at baseline, 2, 4, 8, 12 and 24 weeks after starting entecavir.

Conditions

Interventions

DRUG

Entecavir

Entecavir is the antiviral drug of choice recommended for hepatitis B virus treatment in presence of decompensated cirrhosis

Sponsors & Collaborators

  • Sanjay Gandhi Postgraduate Institute of Medical Sciences

    lead OTHER_GOV

Principal Investigators

  • Amit Goel, DM · Associate Professor, Gastroenterology

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2018-06-30
Completion
2018-12-31

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03345498 on ClinicalTrials.gov