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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00640588
First received: March 17, 2008
Last updated: May 7, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Hepatitis B, Chronic
Drug: Telbivudine
Drug: oral adefovir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: March 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Telbivudine
Drug: Telbivudine
Arm 1: 600 mg/day, oral telbivudina for 24 weeks
Other Names:
  • Sebivo
  • Tyzeka
  • Hepsera
Active Comparator: 2
Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks
Drug: oral adefovir
Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks
Other Name: adefovir

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640588

Locations
Spain
Novartis Investigative Site
Barcelona, Spain
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00640588     History of Changes
Other Study ID Numbers: CLDT600AES01
Study First Received: March 17, 2008
Last Updated: May 7, 2012
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Novartis:
Hepatitis B, chronic
Viral kinetics
Telbivudine
Adefovir
Compliance

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Adefovir
Adefovir dipivoxil
Telbivudine
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014