Prospective Exploratory Study to Describe Hepatitis B Virus (HBV) Kinetics During Treatment With Telbivudine

Prospective Exploratory Study to Describe in CHB naïve and Non-naïve Patients, Hepatitis B Virus (HBV) Kinetics During the First 24 Weeks of Treatment With Telbivudine

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00640588

Acronym

EBEREST

Enrollment

Registered

2008-03-21

Start date

2008-03-31

Completion date

2009-12-31

Last updated

2017-03-28

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

Conditions

Hepatitis B, Chronic

Keywords

Hepatitis B, chronic, Viral kinetics, Telbivudine, Adefovir, Compliance

Brief summary

This study will explore HBV kinetics in CHB patients during the first 24 weeks of treatment with telbivudine

Interventions

DRUGTelbivudine

Arm 1: 600 mg/day, oral telbivudina for 24 weeks

DRUGoral adefovir

Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Male or female, at least 18 years of age. * Documented compensated HBeAg negative CHB defined by baseline HBV serology, DNA and ALT criteria.

Exclusion criteria

* Co-infection with HCV, HDV, or HIV. * Prior therapy with nucleos(t)ides in NAÏVE patient and prior treatment with lamivudine in patients with suboptimal response to adefovir. * History of hepatic decompensation * History of malignancy * Patient has one or more additional known primary or secondary causes of liver disease

Design outcomes

Primary

Measure	Time frame
HBV viral load will be measured by HBV DNA quantification in plasma (log opies/mL) at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks	at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks

Secondary

Measure	Time frame
Liver function assessed at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks HBV genotype measured at baseline	at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks

Countries

Spain

Outcome results

None listed

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