EFFORT Further Extension Study

Efficacy of Long-term Telbivudine Treatment on Histological Improvements in Patients With Chronic Hepatitis B (EFFORT Further Extension Study)

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02826070

Enrollment

130

Registered

2016-07-07

Start date

2015-04-30

Completion date

2017-10-31

Last updated

2016-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Chronic

Keywords

Chronic Hepatitis B

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.

Interventions

DRUGTelbivudine

Telbivudine, 600mg, oral, daily

DRUGAdefovir dipivoxil

Adefovir dipivoxil 10mg, oral, daily

OTHERoff-treatment follow-up

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

1. Patients who completed EFFORT extension study. 2. Patients who had baseline (that is the week 0 of EFFORT study) HBV DNA \<9 Log copies/mL and ALT ≥2×ULN. 3. Patients who are willing to participate in the further extension study. 4. Patient is willing and able to comply with the study drug regimen and all other study requirements. 5. Patients must give written informed consent before any assessment is performed.

Exclusion criteria

1\. Poor compliance judged by investigators

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
Percentage of patients with genotypic resistance among the patients with HBV DNA breakthrough at week 48 and 96 in on-treatment group	week 48, week 96
Incidence of adverse effect at week 48 and 96 in on-treatment group	week 48, week 96
Percentage of patients with glomerular filtration rate (GFR) shifting to >90 mL/min/1.73 m2 for patients with GFR <90 mL/min/1.73 m2 at baseline of EFFORT study at week 48 and 96 in on-treatment group	week 48, week 96
Sustained response rate of durability of HBeAg seroconversion at week 48 and 96 in off-treatment group	week 48, week 96
Percentage of patients who re-achieved ALT normalization and HBV DNA <300 copies/mL in the patients retreated who developed hepatitis flare after stopping treatment in off-treatment group	week 96
Incidence of abnormal laboratory examination at week 48 and 96 in on-treatment group	week 48, week 96
Percentage of hepatitis flare at week 48 and 96 in off-treatment group	week 48, week 96

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026