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

Novartis

Status and phase: Completed; Phase 3

Conditions: Hepatitis B, Chronic

Treatments: Drug: oral adefovir; Drug: Telbivudine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00640588

CLDT600AES01

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

1

Experimental group

Description:

Telbivudine

Treatment:

Drug: Telbivudine

2

Active Comparator group

Description:

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

Treatment:

Drug: oral adefovir