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Completed

NCT Number: NCT00640588

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

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

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Key information

Conditions

Hepatitis B, Chronic Behavior Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Health Behavior Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site

Barcelona, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

telbivudine

Drug

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

Other names: Sebivo, Tyzeka, Hepsera

oral adefovir

Drug

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

Other names: adefovir

Primary outcomes

  1. 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

    Time frame: at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks

Secondary outcomes

  1. Liver function assessed at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks HBV genotype measured at baseline

    Time frame: at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: EBEREST

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 21, 2008
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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