Comparison Between Lamivudine and Entecavir Treatment in Spontaneous Severe Acute Exacerbation

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.

Conditions

• Chronic Hepatitis B

Interventions

DRUG

Lamivudine

Lamivudine 100 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.

DRUG

Entecavir

•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.

Sponsors & Collaborators

• GlaxoSmithKline

  collaborator INDUSTRY

• Taichung Veterans General Hospital

  lead OTHER

Principal Investigators

• Sheng-Shun Yang, M.D. · Taichung Veterans General Hospital

• Yu-Chun Hsu, M.D. · Changhua Christian Hospital

• Shih-Jer Hsu, M.D. · National Taiwan University Hospital Yu-Lin Branch

• Hsueh-Chou Lai, M.D. · China Medical University Hospital

• Chun-Che Lin, M.D. · Chung Shan Medical University

• Jen-Chieh Huang, M.D. · ChengChing Hospital

• Chi-Yi Chen, M.D. · Chia-Yi Christian

• Tsung-Ming Chen, M.D. · Tung's Taiching MetroHarbor Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-07-31

Primary Completion

2016-04-30

Completion

2016-04-30

Countries

• Taiwan

Study Locations