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

Primary Purpose

Hepatitis B, Chronic

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Telbivudine
oral adefovir
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hepatitis B, Chronic focused on measuring Hepatitis B, chronic, Viral kinetics, Telbivudine, Adefovir, Compliance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Telbivudine

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

Outcomes

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

Secondary Outcome Measures

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

Full Information

First Posted
March 17, 2008
Last Updated
March 24, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00640588
Brief Title
Prospective Exploratory Study to Describe Hepatitis B Virus (HBV) Kinetics During Treatment With Telbivudine
Acronym
EBEREST
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic
Keywords
Hepatitis B, chronic, Viral kinetics, Telbivudine, Adefovir, Compliance

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Telbivudine
Arm Title
2
Arm Type
Active Comparator
Arm Description
Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Telbivudine
Other Intervention Name(s)
Sebivo, Tyzeka, Hepsera
Intervention Description
Arm 1: 600 mg/day, oral telbivudina for 24 weeks
Intervention Type
Drug
Intervention Name(s)
oral adefovir
Other Intervention Name(s)
adefovir
Intervention Description
Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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