Brief Summary

The purpose of this study is to compare the adefovir early add-on to rescue therapy strategy, and also explore the efficacy of Lamivudine and adefovir de-novo combination therapy.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

366

participants targeted

Target at P75+ for phase_4

Timeline

Completed

Started Mar 2010

Typical duration for phase_4

Geographic Reach

1 country

24 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.2 years study duration

Study Start

First participant enrolled

March 1, 2010

Completed

14 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2010

Completed

1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2010

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed

Last Updated

October 30, 2013

Status Verified

September 1, 2013

Enrollment Period

2.9 years

First QC Date

March 15, 2010

Last Update Submit

October 28, 2013

Conditions

Compensated Chronic Hepatitis B

Keywords

chronic hepatitis B

Outcome Measures

Primary Outcomes (1)

the proportion of virological breakthrough with confirmed Lamivudine resistant mutants
during 104 weeks study period

Secondary Outcomes (5)

proportion of subjects with hepatitis B virus (HBV) DNA≤300 copies/mL
week 104
Reduction of serum HBV DNA level from baseline (log10 copies/mL) to week 104
baseline, week 104
The proportion of subjects with ALT normalization at week 104
week 104
The proportion of subjects with HBeAg loss and seroconversion at week 104
week 104
The proportion of subjects with HBsAg loss and seroconversion rates at week 104
week 104

Study Arms (3)

early add-on

EXPERIMENTAL

Drug: lamivudine

SOC

ACTIVE COMPARATOR

Patients will receive oral lamivudine 100mg,daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily

Drug: lamivudine

De-novo combination

OTHER

patients in this arm will receive oral lamivudine 100mg and adefovir 10mg for 104 weeks

Drug: lamivudine, adefovir

Interventions

lamivudineDRUG

patients in this arm will receive oral lamivudine 100mg,daily for 24 weeks; if patients with HBV DNA higher than 1000 copies/ml at week 24, add on adefovir to week 104; otherwise, keep lamivudine monotherapy to week 104

early add-on

lamivudine, adefovirDRUG

patients in this arm will receive oral lamivudine 100mg daily and adefovir 10mg for 104 weeks

De-novo combination

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female aged 18-65 years;
Capable of understanding and signing the informed consent. Willing to comply with the study requirements;
Serum HBsAg and HBeAg positive at study screening; Documented chronic hepatitis B infection determined by the presence of serum HBsAg for at least 6 months;

You may not qualify if:

History of decompensated liver function, or current signs/symptoms of decompensation e.g. ascites, variceal bleeding, encephalopathy or spontaneous peritonitis;

Contact the study team to confirm eligibility.