Brief Summary

The purpose of this study is to demonstrate that long-term treatment (up to six years) with telbivudine or telbivudine plus adefovir results in the regression in liver inflammation and fibrosis/cirrhosis.

Trial Health

At Risk

Trial Health Score

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

Trial has exceeded expected completion date

Enrollment

130

participants targeted

Target at P50-P75 for phase_4

Timeline

Completed

Started Apr 2015

Typical duration for phase_4

Geographic Reach

1 country

20 active sites

Status

unknown

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

2.5 years study duration

Study Start

First participant enrolled

April 1, 2015

Completed

1.2 years until next milestone

First Submitted

Initial submission to the registry

June 27, 2016

Completed

10 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed

Last Updated

July 7, 2016

Status Verified

June 1, 2016

Enrollment Period

1.5 years

First QC Date

June 27, 2016

Last Update Submit

July 4, 2016

Conditions

Hepatitis B, Chronic

Keywords

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

Percentage of patients with histological improvement (≥2-point decrease in the Knodell necroinflammatory score and no worsening in Ishak fibrosis score).
Week 48

Secondary Outcomes (12)

Percentage of patients achieving hepatitis B virus (HBV) DNA <300copies/mL at week 48 and 96 in on-treatment group
week 48, week 96
Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48 and 96 in on-treatment group
week 48, week 96
Percentage of patients with HBsAg loss or HBsAg seroconversion at week 48 and 96 in on-treatment group
week 48, week 96
The percentage of patients with alanine aminotransferase (ALT) normalization at week 48 and 96 in on-treatment group
week 48, week 96
Percentage of patients with HBV DNA breakthrough at week 48 and 96 in on-treatment group
week 48, week 96
+7 more secondary outcomes

Study Arms (2)

Off-treatment

OTHER

Patients who had stopped treatment during EFFORT extension study could receive 2-year off-treatment follow-up. All the patients in Part I will be followed up at the interval of 12 weeks. For these patients, if they have hepatitis flare during follow-up, they will be re-treated with telbivudine combined with adefovir for the left study period ( the total study period is 2 years) and followed up at the interval of 12 weeks. Hepatitis flare is defined as HBV DNA\>4 Log10 copies/mL with either ALT≥5 times upper limit of normal (ULN) or TBIL≥2×ULN，or 2 ≤ALT ≤5 ×ULN (at two consecutive visits at least 2 weeks apart) and total bilirubin (TBIL) \<2×ULN.

Other: off-treatment follow-up

On-treatment

OTHER

Patients with continuous treatment during EFFORT extension study will continue treatment, without off-treatment rule in the further extension study. The treatment strategy is depended on the HBV DNA level of each individual, that is, for patients with negative HBV DNA level (defined as HBV DNA \<20 IU/mL) will continue their previous treatment strategy; and for patients with positive HBV DNA level (defined as HBV DNA\>=20 IU/mL) will receive the combination therapy of telbivudine and adefovir, irrespective of their previous treatment strategy. All the patients in Part II will be followed up at the interval of 24 weeks until they complete the 2-year on-treatment follow-up. Patients will be conducted liver biopsy at the sixth year of treatment. All the patients with telbivudine monotherapy will be switched to telbivudine plus adefovir once confirmed HBV DNA breakthrough developed.

Drug: TelbivudineDrug: Adefovir dipivoxil

Interventions

TelbivudineDRUG

Telbivudine, 600mg, oral, daily

On-treatment

Adefovir dipivoxilDRUG

Adefovir dipivoxil 10mg, oral, daily

On-treatment

off-treatment follow-upOTHER

Off-treatment

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Patients who completed EFFORT extension study.
Patients who had baseline (that is the week 0 of EFFORT study) HBV DNA \<9 Log copies/mL and ALT ≥2×ULN.
Patients who are willing to participate in the further extension study.
Patient is willing and able to comply with the study drug regimen and all other study requirements.
Patients must give written informed consent before any assessment is performed.

You may not qualify if:

\. Poor compliance judged by investigators

Contact the study team to confirm eligibility.