Comparison Between Lamivudine and Entecavir Treatment in Spontaneous Severe Acute Exacerbation
Status:
Terminated
Trial end date:
2016-04-01
Target enrollment:
Participant gender:
Summary
This is a prospective, observational, open-label, 2-arm, parallel, multi-center study.
Patients with HBV-associated severe acute exacerbation for whom the treatment with NRTI (such
as lamivudine and entecavir) is medically recommended will be screened for eligibility. To
target 74 evaluable subjects, approximately 82 patients should be recruited into this trial.
After enrollment, all eligible subjects will be randomly assigned to one of the antiviral
treatments below.
- Cohort 1: Lamivudine 100 mg p.o. q.d.
- Cohort 2: Entecavir 0.5 mg p.o. q.d. This process will be stratified by prolonged PT, <
4 sec / 4-6 sec / > 6 sec. Both lamivudine and entecavir will be taken once daily and
the first dose of observational drug should be administered on Day 1. The observational
period of individual subject will be 12 weeks; however, both treatments could be
continued after the end of study based on physician's clinical judgment.
The efficacy and safety data will be collected at baseline, 3, 5, 8, 15, 22, 29, 85, and 180
days after initiation of antiviral treatment. All assessments should be conducted based on
routine practice of each hospital. Only the analysis of HBV DNA and anti-HDV will be
performed in the central lab. For patients who are willing to provide the residual samples of
HBV DNA assessment, the blood samples will be preserved appropriately. All AE(s) and SAE will
be followed until resolution or the event is considered stable.