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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
History of Changes
  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:

U.S. FDA Resources

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

ClinicalTrials.gov processed this record on May 23, 2013