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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:
ClinicalTrials.gov Identifier:
NCT00640588
First Posted: March 21, 2008
Last Update Posted: March 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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 ( Novartis Pharmaceuticals ):

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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00640588


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

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00640588     History of Changes
Other Study ID Numbers: CLDT600AES01
First Submitted: March 17, 2008
First Posted: March 21, 2008
Last Update Posted: March 28, 2017
Last Verified: March 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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
Telbivudine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents