Comparison Between Lamivudine and Entecavir Treatment in Spontaneous Severe Acute Exacerbation

PHASE4TerminatedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

April 30, 2016

Study Completion Date

April 30, 2016

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."

Trial Locations (8)

407

Taichung Veterans General Hospital, Taichung

435

Tung's Taiching MetroHarbor Hospital, Taichung

500

Changhua Christian Hospital, Changhua

640

National Taiwan University Hospital Yu-Lin Branch, YuLin

40201

Chung Shan Medical University Hospital, Taichung

40447

China Medical University Hospital, Taichung

40764

ChengChing Hospital, Taichung

Unknown

Chia-Yi Christian, Chiayi City

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Taichung Veterans General Hospital

OTHER

NCT01627223 - Comparison Between Lamivudine and Entecavir Treatment in Spontaneous Severe Acute Exacerbation | Biotech Hunter | Biotech Hunter