EFFicacy Optimization Research of Telbivudine Therapy

A Two-year, Randomized, Controlled, Open-label, Virologic Response Adaptive Design, Multicenter Study to Optimize Antiviral Efficacy of Telbivudine in Adult Patients With HBeAg Positive Chronic Hepatitis B (EFFORT Study)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00962533

Acronym

EFFORT

Enrollment

606

Registered

2009-08-20

Start date

2009-08-31

Completion date

2012-08-31

Last updated

2013-01-31

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 trial is to prove that the strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy.

Interventions

DRUGtelbivudine

telbivudine, 600mg, oral, daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Male or female, from 18 (inclusive) to 65 (inclusive) years of age * HBsAg and HBeAg positive for over six months * 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

Exclusion criteria

* Detected M204I/V, N236T, A181V/T mutation in patient serum HBV DNA at Screening visit * Patient has a history of or clinical signs/symptoms of hepatic decompensation * Patient has a history of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC * Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
To demonstrate the percentage of patients achieving HBV DNA< 300copies/mL at Week 104 in Group I is superior than that in Group II	Week 104

Secondary

Measure	Time frame
Percentage of patients achieving HBV DNA <60IU/mL (300copies/mL) at Week 52	week 52
Serum HBV DNA reduction from baseline at week 104	week 104
Percentage of patients with HBeAg loss & HBeAg seroconversion at week104 in patients with HBeAg positive at baseline	week 104
Percentage of patients with HBV DNA<300copies/mL AND HBeAg loss or seroconversion at Week 104 in patients with positive HBeAg at baseline	week 104
Serum HBV DNA reduction from baseline at week 52	week 52

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026